FDA Product Code
FDA Product Code LIT — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.1250
510(k) Clearances — 405 records · page 1 of 5
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K260416 | ZYLOX Hippo PTA Balloon Dilatation Catheter | Zylox Medtech Co., Ltd. | 2026-09-21 | Traditional | PDF ↗ |
| K254212 | NC PTA Balloon Dilatation Catheter | Kossel Medtech (Suzhou) Co., Ltd. | 2026-09-16 | Traditional | PDF ↗ |
| K260304 | WAVE PTA Balloon Catheter | WAVE Medical AG | 2026-05-20 | Traditional | PDF ↗ |
| K252512 | Armada 14 NC PTA Catheter | ABBOTT MEDICAL | 2026-02-13 | Traditional | PDF ↗ |
| K251915 | Amethyst HP PTA OTW 0.035 Catheter | Natec Medical , Ltd. | 2025-12-18 | Traditional | PDF ↗ |
| K250706 | Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters; Passeo-14 Peripheral Dilatation Catheter; Oscar Peripheral Multifunctional Catheter System; Pantera Pro Percutaneous Transluminal Coronary Angioplasty Catheter; Pantera LEO Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter | Biotronik, Inc. | 2025-04-04 | Special | PDF ↗ |
| K243704 | Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon Dilatation Catheter; Parafleet SC 035 PTA Balloon Dilatation Catheter | Brosmed Medical Co., Ltd. | 2025-02-27 | Traditional | PDF ↗ |
| K241040 | Amethyst HP PTA OTW 0.035 Catheter | Natec Medical , Ltd. | 2024-12-18 | Traditional | PDF ↗ |
| K242419 | 018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter | Creagh Medical Ltd. Dba Surmodics, Inc. | 2024-11-15 | Traditional | PDF ↗ |
| K241740 | Finesse Injectable PTA Balloon Dilatation Catheter | Summa Therapeutics | 2024-07-16 | Special | PDF ↗ |
| K241711 | Oscar Peripheral Multifunctional Catheter system | Biotronik, Inc. | 2024-07-11 | Special | PDF ↗ |
| K241683 | Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031404020 ); Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031406020); Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031408020); Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031410020); Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031412020); Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031415020); Sterling MONORAIL PTA Balloon Dilatation Catheter (H749390314 | Boston Scientific Corporation | 2024-07-10 | Special | PDF ↗ |
| K241025 | JADE PLUS PTA Balloon Dilatation Catheter | OrbusNeich Medical (Shenzhen) Co., Ltd. | 2024-06-11 | Traditional | PDF ↗ |
| K231402 | HP PTA Balloon Dilatation Catheter | Kossel Medtech (Suzhou) Co., Ltd. | 2023-12-20 | Traditional | PDF ↗ |
| K230263 | Finesse Injectable PTA Balloon Dilatation Catheter | Summa Therapeutics, LLC | 2023-05-26 | Traditional | PDF ↗ |
| K214009 | D·Kaptain PTA High Pressure Balloon Dilatation Catheter | Dk Medical Technology Co., Ltd. | 2023-04-05 | Traditional | PDF ↗ |
| K230191 | Arise UHP Dilatation Catheter | Creagh Medical, Ltd. | 2023-03-22 | Traditional | PDF ↗ |
| K222065 | Passeo-35 Xeo Peripheral Dilatation Catheter | Biotronik, Inc. | 2023-02-16 | Traditional | PDF ↗ |
| K223177 | Highlander 014 PTA Balloon Dilatation Catheter | C.R. Bard, Inc. | 2023-01-20 | Traditional | PDF ↗ |
| K221245 | PTA Balloon Dilatation Catheter | Kossel Medtech (Suzhou) Co., Ltd. | 2022-12-14 | Traditional | PDF ↗ |
| K221414 | ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter | Silk Road Medical, Inc. | 2022-09-02 | Traditional | PDF ↗ |
| K221832 | SABER .014 PTA Dilatation Catheter; SABERX .014 PTA Dilatation Catheter | Cordis US Corp | 2022-08-22 | Traditional | PDF ↗ |
| K212215 | Tiche PTA Balloon Dilatation Catheter | Brosmed Medical Co., Ltd. | 2022-07-19 | Traditional | PDF ↗ |
| K214038 | Oscar Peripheral Multifunctional Catheter system | Biotronik, Inc. | 2022-07-06 | Traditional | PDF ↗ |
| K220410 | Ebony HP PTA OTW 0.035 Catheter | Natec Medical , Ltd. | 2022-06-29 | Traditional | PDF ↗ |
| K221339 | Paladin Carotid Post-Dilation Balloon System with Integrated Embolic Protection | Contego Medical, Inc. | 2022-06-09 | Special | PDF ↗ |
| K221057 | Viatrac 14 Plus Peripheral Dilatation Catheter | Abbott Vascular | 2022-05-05 | Special | PDF ↗ |
| K213631 | Chocolate PTA Balloon Catheter | Medtronic, Inc. | 2021-12-15 | Special | PDF ↗ |
| K201246 | PTA Balloon Catheter (PVQ), MIT PTA Balloon Catheter (PVQ) | Qualimed USA, LLC | 2021-08-03 | Traditional | PDF ↗ |
| K211044 | Sublime Radial Access 018 RX Dilatation Catheter | Creagh Medical Ltd. (A Wholly Owned Subsidiary of Surmodics, | 2021-06-16 | Special | PDF ↗ |
| K210626 | SABER .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter | Cordis Corporation | 2021-04-23 | Traditional | PDF ↗ |
| K202231 | JADE | OrbusNeich Medical (Shenzhen) Co., Ltd. | 2020-12-10 | Traditional | PDF ↗ |
| K202800 | Pacific Plus PTA Catheter | Medtronic Vascular,Inc(Formerly D.B.A Ev3 Inc.,Covidien, LLC) | 2020-11-18 | Traditional | PDF ↗ |
| K201377 | SABERX RADIANZ Percutaneous Transluminal Angioplasty Dilatation Catheter | Cordis Corporation | 2020-10-09 | Traditional | PDF ↗ |
| K201170 | Athletis PTA Balloon Dilatation Catheter | Boston Scientific Corporation | 2020-09-15 | Traditional | PDF ↗ |
| K201333 | SABER .035 PTA Dilatation Catheter | Cordis Corporation | 2020-09-11 | Traditional | PDF ↗ |
| K201794 | Jade | OrbusNeich Medical (Shenzhen) Co., Ltd. | 2020-07-28 | Special | PDF ↗ |
| K192399 | Infinity Angioplasty Balloon Catheter | Infinity Angioplasty Balloon Company, LLC | 2020-05-20 | Traditional | PDF ↗ |
| K200700 | Surmodics Sublime Radial Access 014 RX PTA (Percutaneous Transluminal Angioplasty) Dilatation Catheter | Creagh Medical, Ltd. | 2020-05-14 | Traditional | PDF ↗ |
| K191275 | AllInCath 035M PTA Balloon Dilatation Catheter | Nexstep Medical | 2020-01-15 | Traditional | PDF ↗ |
| K192907 | Advocate PTA Catheter | Merit Medical Systems, Inc. | 2019-11-26 | Traditional | PDF ↗ |
| K190037 | Cronus HP PTA Balloon Catheter | Nipro Medical Corporation | 2019-10-24 | Traditional | PDF ↗ |
| K192318 | Ultraverse 014 and 018 PTA Balloon Dilatation Catheters | Bard Peripheral Vascular, Inc. | 2019-10-03 | Traditional | PDF ↗ |
| K190753 | EverCrossTM 0.035 OTW PTA Dilatation Catheter | Medtronic, Inc. (Formerly D.B.A. Ev3, Inc. Covidien, LLC.) | 2019-04-23 | Special | PDF ↗ |
| K181529 | Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protection | Contego Medical, LLC | 2018-12-06 | Traditional | PDF ↗ |
| K181128 | Paladin Carotid Post-dilation Balloon System with Integrated Embolic Protection (Paladin System) | Contego Medical, LLC | 2018-09-06 | Traditional | PDF ↗ |
| K181323 | Atlas Gold PTA Dilatation Catheter | C.R. Bard, Inc. | 2018-08-03 | Traditional | PDF ↗ |
| K180007 | 018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter | Creagh Medical, Ltd. | 2018-04-19 | Traditional | PDF ↗ |
| K173515 | Admiral Xtreme | Medtronic Vascular | 2018-04-12 | Traditional | PDF ↗ |
| K173894 | Jade PTA Balloon Dilatation Catheter | Orbusneich Medical Trading, Inc. | 2018-02-09 | Traditional | PDF ↗ |
| K172494 | PROTEUS PTA Balloon Catheter with Embolic Capture Feature | Angioslide, Ltd. | 2017-12-15 | Special | PDF ↗ |
| K173621 | Advocate PTA Catheter | Merit Medical Systems, Inc. | 2017-12-13 | Traditional | PDF ↗ |
| K171251 | 014 Hydrophilic Coated PTA Balloon Dilatation Catheter | Creagh Medical | 2017-09-08 | Traditional | PDF ↗ |
| K172033 | Pirouette High Pressure (HP) | Arravasc, Ltd. | 2017-08-31 | Traditional | PDF ↗ |
| K171290 | Vela RX PTA Balloon Dilatation Catheter | Curatia Medical | 2017-07-19 | Traditional | PDF ↗ |
| K170635 | Chameleon PTA Balloon Catheter | Av Medical Technologies, Ltd. | 2017-03-30 | Special | PDF ↗ |
| K170193 | Advance 14LP Low Profile PTA Balloon Dilatation Catheter | Cook Incorporated | 2017-02-13 | Special | PDF ↗ |
| K163231 | Chameleon PTA Balloon Catheter | Av Medical Technologies, Ltd. | 2017-01-17 | Traditional | PDF ↗ |
| K163479 | R2P Metacross RX | KANEKA Corporation | 2017-01-11 | Special | PDF ↗ |
| K160941 | Castor, Achilles and Hermes NC PTA Balloon Dilatation Catheter | Brosmed Medical Co., Ltd. | 2016-12-13 | Traditional | PDF ↗ |
| K162316 | Pirouette 014 | Arravasc, Ltd. | 2016-11-22 | Special | PDF ↗ |
| K162350 | Coyote Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter, Express SD Biliary Monorail Premounted Stent System, Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation Catheter, Sterling Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter, Ultra-Soft SV Monorail Balloon Dilatation Catheter 0.018 | Boston Scientific Corporation | 2016-11-04 | Special | PDF ↗ |
| K161427 | Pirouette 035 | Arravasc Limited | 2016-07-30 | Special | PDF ↗ |
| K160256 | Polux , Minerva and Atropos PTA Balloon Dilatation Catheter | Brosmed Medical Co., Ltd. | 2016-07-29 | Traditional | PDF ↗ |
| K160013 | Crosperio OTW | KANEKA Corporation | 2016-04-29 | Traditional | PDF ↗ |
| K160004 | Crosstella OTW | KANEKA Corporation | 2016-04-29 | Traditional | PDF ↗ |
| K152934 | MMS PTA Balloon Catheter | Micro Medical Solutions, Inc. | 2016-04-25 | Traditional | PDF ↗ |
| K152887 | Crosperio RX PTA Balloon Dilatation Catheter | KANEKA Corporation | 2016-01-22 | Traditional | PDF ↗ |
| K152873 | Crosstella RX Balloon Dilatation Catheter | KANEKA Corporation | 2016-01-22 | Traditional | PDF ↗ |
| K151141 | Cronus HP - High Pressure Peripheral Balloon Catheter | Nipro Medical Corporation | 2016-01-14 | Traditional | PDF ↗ |
| K152665 | PolarCath Peripheral Dilatation System | Nucyro Vascular, LLC | 2015-10-26 | Traditional | PDF ↗ |
| K152240 | Passeo-14 Peripheral Dilatation Catheter | Biotronik, Inc. | 2015-10-08 | Traditional | PDF ↗ |
| K151744 | Passeo-18 Peripheral Dilation Catheter | Biotronik, Inc. | 2015-10-08 | Special | PDF ↗ |
| K152080 | Metacross OTW PTA Balloon Dilatation Catheter | KANEKA Corporation | 2015-09-24 | Traditional | PDF ↗ |
| K151678 | Chameleon PTA Balloon Catheter | Av Medical Technologies, Ltd. | 2015-09-21 | Traditional | PDF ↗ |
| K152230 | Ebony PTA .014 RX Pheripheral Dilatation Catheter | Natec Medical | 2015-09-03 | Special | PDF ↗ |
| K151153 | Pirouette 018 | Arravasc Limited | 2015-08-20 | Traditional | PDF ↗ |
| K150452 | ComboCath OTW PTA Dilatation Catheter | Summa Therapeutics, LLC | 2015-08-13 | Traditional | PDF ↗ |
| K143193 | Symmetry and Symmetry Stiff Shaft Balloon Dilatation Catheters | Boston Scientific | 2015-07-24 | Traditional | PDF ↗ |
| K151317 | Armada 18 PTA Catheter | Abbott Vascular | 2015-07-06 | Special | PDF ↗ |
| K143093 | 0.018 Arrow GPSCath Balloon Dilatation Catheter (150 cm) | Hotspur Technologies, Inc., | 2015-06-24 | Traditional | PDF ↗ |
| K150303 | XXL Vascular Balloon Dilatation Catheter | Boston Scientific Corp | 2015-06-15 | Traditional | PDF ↗ |
| K143041 | Ebony PTA 0.014'' over the wire Catheter and Ebony PTA 0.018 over the wire Catheter | Natec Medical , Ltd. | 2015-06-04 | Special | PDF ↗ |
| K142954 | PTA 14 Balloon Dilatation Catheter OTW | Texasmedical Technologies, Inc. | 2015-05-28 | Traditional | PDF ↗ |
| K143561 | ELM PTA Balloon Dilatation Catheter | O'Connell Regulatory Consultants, Inc. | 2015-05-19 | Traditional | PDF ↗ |
| K150946 | FLASH Ostial System OTW-6.0mm x 12mm x 80cm, FLASH Ostial System OTW-6.0mm x 12mm x 135cm, FLASH Ostial System OTW-7.0mm x 12mm x 80cm, FLASH Ostial System OTW-7.0mm x 12mm x 135cm | Ostial Corporation | 2015-05-08 | Special | PDF ↗ |
| K143036 | Ebony PTA 0.035 Peripheral Dilatation Catheter | Natec Medical , Ltd. | 2015-03-30 | Traditional | PDF ↗ |
| K143652 | Vector PTA Balloon Dilatation Catheter | Vector Corporation, LLC | 2015-02-26 | Special | PDF ↗ |
| K142459 | Ebony PTA 0.014 RX Peripheral Dilatation Catheter | Natec Medical , Ltd. | 2015-02-03 | Traditional | PDF ↗ |
| K142379 | Passeo-35 PTA Catheter | Biotronik, Inc. | 2014-12-05 | Special | PDF ↗ |
| K142654 | Fortrex 0.035 OTW PTA Balloon Catheter | Covidien, LLC | 2014-10-28 | Traditional | PDF ↗ |
| K141150 | PTA BALLOON DILATATION CATHETER | Boston Scientific Corp | 2014-09-25 | Traditional | PDF ↗ |
| K142261 | Ultraverse 035 PTA Balloon Dilatation Catheter | Bard Peripheral Vascular, Inc. | 2014-09-24 | Traditional | PDF ↗ |
| K142300 | Arrow GPSCath Balloon Dialation Catheter (150 cm) | Hotspur Technologies, Inc., | 2014-09-17 | Special | PDF ↗ |
| K141521 | MUSTANG BALLOON DILATATION CATHETER/CHARGER PTA BALLOON DILATATION CATHETER | Boston Scientific Corporation | 2014-08-21 | Special | PDF ↗ |
| K141118 | NANOCROSS EITE 0.014 OVER-THE-WIRE PTA BALLOON DILATATION CATHETER | Ev3, Inc. | 2014-07-18 | Special | PDF ↗ |
| K141112 | STERLING OVER-THE WIRE PTA BALLOON DILATATION CATHETER | Boston Scientific | 2014-07-16 | Special | PDF ↗ |
| K140351 | ARROW GPSCATH BALLOON DILATATION CATHETER | Hotspur Technologies,Inc Subsidiary of Teleflex ME | 2014-07-02 | Traditional | PDF ↗ |
| K133861 | FLASH OSTIAL SYSTEM OTW-7.0MMX17MMX135CM, FLASH OSTIAL SYSTEM OTW-7.0MMX17MMX80CM | Ostial Corporation | 2014-07-02 | Traditional | PDF ↗ |
| K133843 | SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY DILATATION CATHETER | Cordis Corporation | 2014-06-27 | Traditional | PDF ↗ |
Product code LIT · Class II · Cardiovascular. Data: openFDA.