FDA Product Code
FDA Product Code LJS — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General Hospital
- 21 CFR Citation
- 880.5970
510(k) Clearances — 302 records · page 1 of 4
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K260929 | Neonav ECG Tip Location System | Navi Medical Technologies | 2026-04-17 | Special | PDF ↗ |
| K252373 | BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology; BioFlo Midline Catheter; Xcela Power Injectable PICC; Xcela PICC with PASV Valve Technology; Xcela Hybrid PICC with PASV Valve Technology | Spectrum Vascular | 2025-12-16 | Traditional | PDF ↗ |
| K252792 | PM2 System with ECGuide Connector | Piccolo Medical, Inc. | 2025-11-17 | Special | PDF ↗ |
| K243458 | HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001301); HydroPICC 4Fr Single Lumen Marked catheter, 70 cm guidewire - Basic Kit (70001302); HydroPICC 4Fr Single Lumen Marked catheter - Maximal Barrier kit (70001304); HydroPICC 5Fr Dual Lumen Marked catheter, 130 cm guidewire - Basic Kit (70002301); HydroPICC 5Fr Dual Lumen Marked catheter, 70 cm guidewire - Basic Kit (70002302); HydroPICC 5Fr Dual Lumen Marked catheter - Maximal Barrier kit (70002304); Hydr | Access Vascular, Inc. | 2025-08-01 | Traditional | PDF ↗ |
| K251212 | Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr HydroPICC Catheter (PICC-252CM) (PICC-252CM) | Access Vascular, Inc. | 2025-07-01 | Special | PDF ↗ |
| K243484 | PM2+ System and SmartPICC Stylet | Piccolo Medical, Inc. | 2025-05-29 | Traditional | PDF ↗ |
| K241587 | pilot TLS | Vygon Corporation | 2025-02-26 | Traditional | PDF ↗ |
| K241910 | Neonav ECG Tip Location System | Navi Medical Technologies | 2025-01-19 | Traditional | PDF ↗ |
| K243941 | HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001201); HydroPICC 4Fr Single Lumen Marked catheter, 70 cm guidewire - Basic Kit (70001202); HydroPICC 4Fr Single Lumen Marked catheter, Maximal Barrier kit (70001204); HydroPICC 4Fr Single Lumen Marked catheter, Mobile Maximal Barrier Kit (90001204) | Access Vascular, Inc. | 2025-01-17 | Special | PDF ↗ |
| K240486 | PM2 System and ECGuide Connector | Piccolo Medical, Inc. | 2024-09-08 | Traditional | PDF ↗ |
| K233149 | CATHTONG III Tapered PICC Catheter | L&Z Us, Inc. | 2023-12-01 | Special | PDF ↗ |
| K230669 | L-Cath Single and Dual Lumen Catheters, L-Cath Midline Catheters | Argon Medical Devices | 2023-11-30 | Traditional | PDF ↗ |
| K232594 | CATHTONG II PICC Catheter | L&Z Us, Inc. | 2023-09-22 | Special | PDF ↗ |
| K232571 | CATHTONG II PICC Catheter | L&Z Us, Inc. | 2023-09-22 | Special | PDF ↗ |
| K222232 | Sherlock 3CG® Tip Positioning System (TPS) Stylet/T-Lock Assembly | Bard Access Systems, Inc. | 2022-08-24 | Special | PDF ↗ |
| K220363 | VPS Rhythm DLX Device with TipTracker Technology | Arrow International, LLC (A subsidiary of Teleflex, Inc.) | 2022-08-22 | Traditional | PDF ↗ |
| K213550 | HydroPICC 5F Dual Lumen Catheter | Access Vascular, Inc. | 2022-05-04 | Traditional | PDF ↗ |
| K210264 | BD PowerPiCC Catheter | Bard Access Systems, Inc. | 2021-07-30 | Traditional | PDF ↗ |
| K201452 | Groshong NXT PICC Catheter | C.R. Bard, Inc. | 2021-03-12 | Traditional | PDF ↗ |
| K200037 | Piccolo Medical SmartPICC System | Piccolo Medical, Inc. | 2021-01-22 | Traditional | PDF ↗ |
| K192246 | Biowy PICC Catheter S Kit | Biowy Corporation | 2020-04-30 | Traditional | PDF ↗ |
| K193015 | HydroPICC (PICC-142) | Access Vascular, Inc. | 2020-02-20 | Traditional | PDF ↗ |
| K180546 | Jet Power Injectable PICC | Jet Medical, Inc. | 2018-11-21 | Traditional | PDF ↗ |
| K181904 | 5 FR Dual Lumen Piper PICC | Piper Access, LLC | 2018-09-25 | Traditional | PDF ↗ |
| K180560 | Sherlock 3CG+ T ip Confirmation System | C.R. Bard, Inc. | 2018-06-18 | Traditional | PDF ↗ |
| K173956 | Biowy PlCC Catheter | Biowy Corporation | 2018-05-21 | Traditional | PDF ↗ |
| K180548 | 3F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherers; 3F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherters with SOLO Valve Technology | C.R. Bard, Inc (Bard Has Joined Bd) | 2018-04-26 | Special | PDF ↗ |
| K172511 | Hickman TriFusion Catheter | C.R. Bard, Inc. | 2018-04-20 | Traditional | PDF ↗ |
| K180567 | C3 Wave System | Medical Components, Inc. (dba MedComp) | 2018-04-12 | Special | PDF ↗ |
| K172899 | Vygon PICCs | Vygon USA | 2018-02-26 | Traditional | PDF ↗ |
| K171994 | Silicone Peripherally Inserted Central Venous Catheter Set/Tray | Cook Incorporated | 2018-02-22 | Traditional | PDF ↗ |
| K172885 | HydroPICC | Access Vascular, Inc. | 2018-02-20 | Traditional | PDF ↗ |
| K170934 | C3 Wave System | Medical Components, Inc (Dba Medcomp_ | 2017-12-06 | Traditional | PDF ↗ |
| K171931 | Celerity ECG Cable Accessory Pack | Medcomp (Medical Components, Inc.) | 2017-10-26 | Traditional | PDF ↗ |
| K172397 | Sherlock 3CG Tip Positioning System Stylet | C.R. Bard, Inc. | 2017-09-29 | Special | PDF ↗ |
| K172039 | CATHTONG II PICC Catheter | L&Z Us, Inc. | 2017-08-03 | Special | PDF ↗ |
| K170486 | CATHTONG II PICC Catheter | L&Z Us, Inc. | 2017-05-25 | Special | PDF ↗ |
| K162441 | PowerPICC Provena Catheters with SOLO Valve Technology | C.R. Bard, Inc. | 2017-04-24 | Traditional | PDF ↗ |
| K163452 | PICC Maximal Barrier Nursing Kit | Navilyst Medical, Inc. | 2017-02-03 | Special | PDF ↗ |
| K160925 | VPS Rhythm Device with TipTracker Technology | Arrow International, Inc. (A Subsidiary of Teleflex, Inc.) | 2016-12-22 | Traditional | PDF ↗ |
| K162443 | PowerPICC Provena Catheters | C.R. Bard, Inc. | 2016-10-25 | Special | PDF ↗ |
| K161496 | Turbo-Flo PICC Sets | Cook Incorporated | 2016-10-07 | Traditional | PDF ↗ |
| K161765 | CG+ Arrow JACC | Arrow International, Inc. (Subsidiary of Teleflex | 2016-09-06 | Special | PDF ↗ |
| K153469 | Cathtong I PICC Catheter | L&Z Us, Inc. | 2016-09-01 | Special | PDF ↗ |
| K151985 | PowerPICC® EtOH Catheter and PowerPICC SOLO®2 EtOH Catheter | C.R. Bard, Inc. | 2016-06-14 | Traditional | PDF ↗ |
| K152819 | Amecath Peripheral inserted Central Venous Catheter Sets | Ameco Medical Industries | 2016-02-05 | Traditional | PDF ↗ |
| K153487 | CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUS | Arrow International, Inc. (Subsidiary of Teleflex, Inc.) | 2016-02-04 | Special | PDF ↗ |
| K153423 | CG+ Arrow JACC powered by Arrow VPS Stylet, CG+ Arrow JACC | Arrow International, Inc. (Subsidiary of Teleflex, Inc.) | 2016-01-28 | Special | PDF ↗ |
| K152261 | PICC Tip Positioning Aid | Nostix, LLC | 2015-10-21 | Traditional | PDF ↗ |
| K152409 | Xcela PICC with PASV, Xcela Hybrid PICC with PASV, Xcela Power Injectable PICC | Navilyst Medical, Inc. | 2015-09-24 | Special | PDF ↗ |
| K143238 | C3 Wave | Medcomp ( Medical Components) | 2015-04-24 | Traditional | PDF ↗ |
| K150527 | Xcela Power Injectable PICC | Navilyst Medical, Inc. | 2015-03-31 | Special | PDF ↗ |
| K150448 | NMI PICC III and NMI PICC IV | Navilyst Medical, Inc. | 2015-03-19 | Special | PDF ↗ |
| K142889 | Celerity PICC Tip Confirmation System | AngioDynamics, Inc. | 2015-01-27 | Traditional | PDF ↗ |
| K141634 | NAUTILUS DELTA | Romedex International Srl | 2015-01-27 | Abbreviated | PDF ↗ |
| K142267 | Sherlock 3CG Tip Positioning System Stylet | C.R. Bard, Inc. | 2014-10-17 | Traditional | PDF ↗ |
| K142616 | PICC Maximal Barrier Nursing Kit | Navilyst Medical, Inc. | 2014-10-14 | Special | PDF ↗ |
| K141633 | PRO-PICC WITH VALVE TECHNOLOGY | Medical Components, Inc. | 2014-09-29 | Traditional | PDF ↗ |
| K141818 | TURBO-JECT PICC SETS | Cook Corporated | 2014-08-05 | Special | PDF ↗ |
| K141151 | CT MIDLINE | Medcomp (Medical Components, Inc.) | 2014-07-08 | Traditional | PDF ↗ |
| K140799 | CELERITY SYSYEM | Medcomp (Medical Components, Inc.) | 2014-06-13 | Traditional | PDF ↗ |
| K140345 | THE SHERLOCK 3CG TIP CONFIRMATION SYSTEM (TCS) | C.R. Bard, Inc. | 2014-03-14 | Special | PDF ↗ |
| K140266 | NMI PICC IV | Navilyst Medical, Inc. | 2014-03-05 | Special | PDF ↗ |
| K133634 | SPECTRUM TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET | Cook, Inc. | 2013-12-23 | Special | PDF ↗ |
| K133264 | NMI PICC III | Navilyst Medical, Inc. | 2013-11-20 | Special | PDF ↗ |
| K132567 | ARGYLE PERIPHERALLY INSERTED CENTRAL CATHETER SINGLE LUMEN, ARGYLE PERIPHERALLY INSERTED CENTRAL CATHETER DUAL LUMEN | Covidien | 2013-11-05 | Special | PDF ↗ |
| K130897 | MEDCOMP VASCU-PICC WITH VALVE | Medcomp ( Medical Components) | 2013-10-22 | Traditional | PDF ↗ |
| K132885 | TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC) SET | Cook Incorporated | 2013-10-11 | Special | PDF ↗ |
| K132334 | TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC) SET | Cook, Inc. | 2013-08-16 | Special | PDF ↗ |
| K131687 | 6F X 60CM TRIPLE PRO-LINE CT BASIC IR SET | Medical Components, Inc. | 2013-08-16 | Traditional | PDF ↗ |
| K131942 | NMI PICC III CATHETER, NMI HPICC III CATHETER | Navilyst Medical, Inc. | 2013-07-31 | Special | PDF ↗ |
| K130507 | FOOTPRINT MEDICAL POLYURETHANE PICC CATHETER | Footprint Medical, Inc. | 2013-06-03 | Special | PDF ↗ |
| K123617 | 3F PRO-PICC | Medical Components, Inc. | 2013-05-15 | Traditional | PDF ↗ |
| K131038 | NMI PICC MAXIMAL BARRIER NURSING KITS | Navilyst Medical, Inc. | 2013-05-09 | Special | PDF ↗ |
| K130876 | CG+ ARROW PICC POWERED BY ARROW VPS STYLET | Arrow International, Inc. | 2013-04-26 | Special | PDF ↗ |
| K130034 | UNI-PICC | Health Line International Corporation | 2013-03-08 | Traditional | PDF ↗ |
| K123759 | CG+ ARROW PICC POWERED BY ARROW VPS STYLET | Arrow International, Inc. (Subsidiary of Teleflex | 2013-01-03 | Special | PDF ↗ |
| K122423 | VASU-PICC | Medical Components, Inc. | 2012-12-12 | Traditional | PDF ↗ |
| K121501 | ARROW JUGULAR AXILLO-SUBCLAVIAN CENTRAL CATHETER (JACC) | Arrow International (Subsidiary of Teleflex Inc.) | 2012-11-29 | Traditional | PDF ↗ |
| K113225 | NYLUS PICC | Semprus Biosciences | 2012-11-06 | Traditional | PDF ↗ |
| K122882 | NMI HPICC III | Navilyst Medical, Inc. | 2012-10-18 | Special | PDF ↗ |
| K122545 | CG+ ARROW PICC POWERED BY ARROW VPS STYLET | Arrow International (Subsidiary of Teleflex Inc.) | 2012-09-20 | Special | PDF ↗ |
| K121941 | ARROW PICC POWERED BY ARROW VPS STYLET | Arrow International (Subsidiary of Teleflex Inc.) | 2012-09-07 | Special | PDF ↗ |
| K121089 | NMI PICC III | Navilyst Medical, Inc. | 2012-08-23 | Traditional | PDF ↗ |
| K121990 | PICC CONVENIENCE KIT | Navilyst Medical, Inc. | 2012-08-03 | Special | PDF ↗ |
| K113277 | ARROWADVANTAGES PRESSURE INJECTABLE PERIPHERALLY INSCRTED CENTRAL CATHETER KITS | Arrow International, Inc. | 2012-06-21 | Traditional | PDF ↗ |
| K121094 | MEDCOMP VASCU-PICC & MIDLINE CATHETERS | Medical Components, Inc. | 2012-06-06 | Special | PDF ↗ |
| K112896 | ARRW EVOLUTION | Arrow International (Subsidiary of Teleflex Inc.) | 2012-05-10 | Traditional | PDF ↗ |
| K120981 | 2.6F X 20CM VASCU-PICC 2.6F X 50CM VASCU-PICC | Medical Components, Inc. | 2012-05-02 | Special | PDF ↗ |
| K120980 | 1.9F X 20CM VASCU-PICC 1.9F X 50CM VASCU-PICC | Medical Components, Inc. | 2012-05-02 | Special | PDF ↗ |
| K113808 | THE SHERLOCK 3CG TIP CONFIRMATION SYSTEM (TCS) | C.R. Bard, Inc. | 2012-03-19 | Traditional | PDF ↗ |
| K113043 | DIRECT ANTIBIOTIC INFUSION KIT | Summit Medical Products, Inc. | 2011-12-20 | Traditional | PDF ↗ |
| K112744 | SAPIENS TIP CONFIRMATION SYSTEM | C.R. Bard, Inc. | 2011-10-20 | Special | PDF ↗ |
| K110914 | TRIPLE LUMEN PFM PICC | Pfm Medical, Inc. | 2011-09-21 | Traditional | PDF ↗ |
| K110627 | NEXSITE 9FR DUAL LUMEN CRITICAL CARE CENTRAL VENOUS CATHETER | Marvao Medical Devices, Ltd. | 2011-08-12 | Traditional | PDF ↗ |
| K111906 | XCELA HYBRID PICC WITH PASV VALVE TECHNOLOGY | Navilyst Medical, Inc. | 2011-07-29 | Special | PDF ↗ |
| K111244 | TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC) | Cook, Inc. | 2011-06-14 | Special | PDF ↗ |
| K102966 | 2.6F X 20CM VASCU-PICC, 2.6F X 50CM VASCU-PICC | Medcomp | 2010-12-21 | Traditional | PDF ↗ |
| K102159 | POWERPICC SV CATHETERS | C.R. Bard, Inc. | 2010-11-17 | Traditional | PDF ↗ |
| K101326 | NMI IC | Navilyst Medical, Inc. | 2010-09-02 | Abbreviated | PDF ↗ |
Product code LJS · Class II · General Hospital. Data: openFDA.