FDA Product Code
FDA Product Code DYB — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.1340
510(k) Clearances — 706 records · page 1 of 8
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K253526 | NAMIC Dilator and Sheath | Medline Industries, LP | 2026-07-29 | Traditional | PDF ↗ |
| K261529 | Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit / Microintroducer Kit (SIS05C); Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set / Microintroducer Kit / Microintroducer Kit (IS01); Introducer Kit / Microintroducer Kit / Introducer Set /Microintroducer Set / Micro Introducer Sheath Set / Introducer Sheath Set (NIS04) | Hartman Medical Group, LLC | 2026-07-06 | Traditional | PDF ↗ |
| K261242 | SimplGuide | Pendracare | 2026-06-25 | Traditional | PDF ↗ |
| K261950 | Health Line Tearaway Introducer | Health Line International Corporation | 2026-06-22 | Traditional | PDF ↗ |
| K261492 | FieldFlex Steerable Sheath | CenterPoint Systems, LLC | 2026-06-05 | Special | PDF ↗ |
| K260606 | Echo Large Bore Introducer Sheath | Echo Medical, LLC | 2026-04-29 | Traditional | PDF ↗ |
| K254248 | Introducer Sheath Set | Cardiocycle Medical(Suzhou) Co., Ltd. | 2026-04-23 | Traditional | PDF ↗ |
| K254279 | Edwards eSheath+ introducer set | Edwards Lifesciences | 2026-04-17 | Traditional | PDF ↗ |
| K260091 | Aventus Introducer Sheath | Inquis Medical | 2026-04-13 | Traditional | PDF ↗ |
| K260839 | Protaryx Transseptal Puncture Device (PTX2-001) | Protaryx Medical, Inc. | 2026-04-10 | Traditional | PDF ↗ |
| K260942 | AuST Steerable Sheath | CenterPoint Systems, LLC | 2026-04-07 | Special | PDF ↗ |
| K260459 | VANES Delivery System (VDS) | Zoll Respicardia, Inc. | 2026-04-06 | Traditional | PDF ↗ |
| K260626 | Multiflex Steerable Sheath 17.5F | Vizaramed, Inc. | 2026-03-26 | Special | PDF ↗ |
| K260163 | AuST CSP Introducer | CenterPoint Systems, LLC | 2026-02-19 | Special | PDF ↗ |
| K254236 | Peel-Away Introducer Sheath | VascuTech Medical, LLC | 2026-02-09 | Traditional | PDF ↗ |
| K253652 | Genie MAX Large Bore Introducer Sheath | Cultiv8 1, LLC | 2026-01-22 | Traditional | PDF ↗ |
| K252508 | Intri26 Introducer Sheath | Inari Medical, Inc. | 2025-12-17 | Traditional | PDF ↗ |
| K253741 | VStick Vascular Access Set | Argon Medical Devices, Inc. | 2025-12-15 | Special | PDF ↗ |
| K252309 | PerQseal Introducers | Vivasure Medical Limited | 2025-10-23 | Traditional | PDF ↗ |
| K251838 | Introducer Sheath Set | Cardiocycle Medical(Suzhou) Co., Ltd. | 2025-10-21 | Traditional | PDF ↗ |
| K252766 | 14Fr Low Profile Introducer Kit | Abiomed, Inc. | 2025-10-08 | Special | PDF ↗ |
| K252441 | Primero Safe Access System | South53, LLC | 2025-09-29 | Traditional | PDF ↗ |
| K252227 | Pounce(TM) Sheath | Surmodics,Inc. | 2025-09-24 | Special | PDF ↗ |
| K252027 | Vertex(TM) Catheter | Jupiter Endovascular | 2025-09-12 | Traditional | PDF ↗ |
| K252364 | Edwards eSheath Optima introducer set | Edwards Lifesciences | 2025-08-29 | Special | PDF ↗ |
| K251051 | AuST Steerable Sheath | CenterPoint Systems, LLC | 2025-04-30 | Special | PDF ↗ |
| K250909 | Prelude Wave Hydrophilic Sheath Introducer | Merit Medical Systems, Inc. | 2025-04-25 | Special | PDF ↗ |
| K243954 | PeriCross Epicardial Access Kit | Circa Scientific, Inc. | 2025-04-24 | Traditional | PDF ↗ |
| K244046 | Edwards eSheath Optima introducer set | Edwards Lifesciences | 2025-03-27 | Traditional | PDF ↗ |
| K243928 | ViaOne Epicardial Access System | Cardiovia , Ltd. | 2025-03-20 | Traditional | PDF ↗ |
| K250468 | iSLEEVE Introducer Set | Boston Scientific | 2025-03-20 | Special | PDF ↗ |
| K250439 | Catapult Guide Sheath; 4F; 15cm (US-34015-F-ST-H); Catapult Guide Sheath; 4F; 45cm (US-34045-F-ST-H); Catapult Guide Sheath; 4F; 60cm (US-34060-F-ST-H); Catapult Guide Sheath; 4F; 90cm (US-34090-F-ST-H); Catapult Guide Sheath; 4F; 130cm (US-34130-F-ST-H); Catapult Guide Sheath; 5F; 15cm (US-35015-F-ST-H); Catapult Guide Sheath; 5F; 45cm (US-35045-F-ST-H); Catapult Guide Sheath; 5F; 45cm; Hockey Stick (US-35045-F-HS-H); Catapult Guide Sheath; 5F; 45cm; Multipurpose (US-35045-F-MP-H); Ca | Contract Medical International, GmbH | 2025-03-16 | Special | PDF ↗ |
| K243493 | Agilis NxT Steerable Introducer Dual-Reach | ABBOTT MEDICAL | 2024-12-13 | Special | PDF ↗ |
| K242520 | Element Vascular Access System | Penumbra, Inc. | 2024-11-20 | Traditional | PDF ↗ |
| K242756 | Introducer Sheath (PFlexi00L065, PFlexi00L070, PFlexi00L075, PFlexi00L080, PFlexi00L090, PFlexi30L065, PFlexi30L070, PFlexi30L075, PFlexi30L080, PFlexi30L090, PFlexi45L065, PFlexi45L070, PFlexi45L075, PFlexi45L080, PFlexi45L090, PFlexi60L065, PFlexi60L070, PFlexi60L075, PFlexi60L080, PFlexi60L090) | Pulnovo Medical (Wuxi) Co., Ltd. | 2024-11-08 | Traditional | PDF ↗ |
| K243061 | SonoStik Guide Wire Introducer | Sonostik, LLC | 2024-11-04 | Special | PDF ↗ |
| K242106 | AuST Steerable Sheath | CenterPoint Systems, LLC | 2024-10-04 | Special | PDF ↗ |
| K241230 | Super Sheath Introducer Sheath S-3N5/1005 S-3N7/1006 S-3W5/1007 S-3W7/1008 | Togo Medikit Co., Ltd. | 2024-09-17 | Traditional | PDF ↗ |
| K240600 | SafeCross Vascular Introducer System (4001) | East End Medical I, LLC | 2024-09-06 | Special | PDF ↗ |
| K242169 | Morph DNA Steerable Introducer Sheath | Biocardia | 2024-08-23 | Special | PDF ↗ |
| K242248 | Introducer Sheath Kits | Beijing Demax Medical Technology Co.,Ltd | 2024-08-22 | Special | PDF ↗ |
| K240957 | Catapult Guide Sheath | Contract Medical International, GmbH | 2024-08-14 | Special | PDF ↗ |
| K241708 | Abiomed 14Fr Low Profile Introducer Kit | Abiomed, Inc. | 2024-08-06 | Traditional | PDF ↗ |
| K241145 | TLAB® Transvenous Liver Biopsy System (TF-18C) | Argon Medical Devices, Inc. | 2024-08-01 | Traditional | PDF ↗ |
| K241370 | Agilis NxT Steerable Introducer Dual-Reach (I-V2-MED) | ABBOTT MEDICAL | 2024-06-13 | Special | PDF ↗ |
| K240829 | AuST Steerable Sheath | CenterPoint Systems, LLC | 2024-05-01 | Traditional | PDF ↗ |
| K240589 | Micropuncture Introducer Sets; Micropuncture Pedal Access Sets | Cook Medical | 2024-03-25 | Special | PDF ↗ |
| K233708 | NaviGo 12F Steerable Intracardiac Catheter Introducer Kit (S12FS-01) | Synaptic Medical Corporation | 2024-02-16 | Traditional | PDF ↗ |
| K233959 | EPi-Ease Epicardial Access Device (EAS) | AtriCure, Inc. | 2024-02-13 | Traditional | PDF ↗ |
| K240004 | CardioCurve Steerable Sheath Small Curl, 40cm (CC-1040S ); CardioCurve Steerable Sheath Medium Curl, 40cm (CC-1040M ); CardioCurve Steerable Sheath Large Curl, 40cm (CC-1040L ); CardioCurve Steerable Sheath Small Curl, 61cm (CC-1061S); CardioCurve Steerable Sheath Medium Curl, 61cm (CC-1061M ); CardioCurve Steerable Sheath Large Curl, 61cm (CC-1061L); CardioCurve Steerable Sheath Small Curl, 71cm (CC-1071S ); CardioCurve Steerable Sheath Medium Curl, 71cm (CC-1071M ); CardioCurve Steer | Circa Scientific, Inc. | 2024-01-31 | Special | PDF ↗ |
| K231227 | SureFlex HD Steerable Sheath, VersaCross HD Steerable Sheath | Baylis Medical Company, Inc. | 2023-12-20 | Traditional | PDF ↗ |
| K233691 | FlexCath Cross Transseptal Solution | Acutus Medical, Inc. | 2023-12-17 | Traditional | PDF ↗ |
| K233646 | Intri24 Introducer Sheath (52-101) | Inari Medical, Inc. | 2023-12-12 | Special | PDF ↗ |
| K233432 | 10F Sheath and Dilator Set | Argon Medical Devices, Inc. | 2023-12-08 | Traditional | PDF ↗ |
| K233503 | 14F iSLEEVE Introducer Set | Boston Scientific Corporation | 2023-11-30 | Special | PDF ↗ |
| K231108 | Talon Transseptal Sheath | Inari Medical, Inc. | 2023-09-27 | Traditional | PDF ↗ |
| K232260 | Thinline Sheath Introducer | Inneuroco, Inc. | 2023-09-27 | Traditional | PDF ↗ |
| K231828 | Pounce Sheath | Surmodics,Inc. | 2023-09-07 | Traditional | PDF ↗ |
| K231412 | CARTO VIZIGO® 8.5F Bi-Directional Guiding Sheath (D-1385-01-S, D-1385-02-S, D-1385-03-S) | Biosense Webster, Inc. | 2023-07-10 | Special | PDF ↗ |
| K230631 | Kodiak Dual Port Coaxial Introducer Kit | Argon Medical Devices | 2023-05-22 | Traditional | PDF ↗ |
| K230704 | RAIN Sheath Tibial Pedal Introducer | Cordis US Corp | 2023-04-24 | Traditional | PDF ↗ |
| K230283 | Peel-Away Introducer (405104, 405108, 405112, 405116, 405118, 405119, 405120, 405122, 405124, 405128, 405129, 405136, 405144, 405145, 405146, 405147, 405149, 405153, 405154, 405254, 405269, 405270, 405404, 405408, 405412, 405416, 405418, 405420, 405422, 405424, 405428) | ABBOTT MEDICAL | 2023-03-01 | Special | PDF ↗ |
| K222184 | Introducer Sheath Kits | Beijing Demax Medical Technology Co.,Ltd | 2023-02-21 | Traditional | PDF ↗ |
| K230051 | 14F iSLEEVE Introducer Set | Boston Scientific Corporation | 2023-02-03 | Special | PDF ↗ |
| K223872 | Low Profile Companion Sheath | Merit Medical Systems, Inc. | 2023-01-19 | Special | PDF ↗ |
| K221655 | Multiflex Steerable Sheath | Vizaramed, Inc. | 2022-11-14 | Traditional | PDF ↗ |
| K222113 | Abiomed 14Fr Low Profile Introducer Set | Abiomed, Inc. | 2022-10-13 | Traditional | PDF ↗ |
| K221914 | Catapult Guide Sheath | Contract Medical International, GmbH | 2022-07-29 | Special | PDF ↗ |
| K213582 | Epicardial Access System | Baylis Medical Company, Inc. | 2022-06-30 | Special | PDF ↗ |
| K221440 | Liverty TIPS Access Set | Bard Peripheral Vascular, Inc. | 2022-05-31 | Traditional | PDF ↗ |
| K220414 | VersaCross Connect Transseptal Dilator | Baylis Medical Company, Inc. | 2022-05-09 | Special | PDF ↗ |
| K220604 | EXTesia Introducer Sheath Set | Curatia Medical Co. | 2022-04-27 | Traditional | PDF ↗ |
| K212392 | Intri24 Sheath | Inari Medical, Inc. | 2022-04-01 | Traditional | PDF ↗ |
| K213492 | Dib UltraNav Transseptal Catheter System | Dib Ultranav Medical, LLC | 2022-03-24 | Traditional | PDF ↗ |
| K212626 | PathBuilder Transseptal Guiding Introducer | Shanghai Microport EP Medtech Co., Ltd. | 2022-03-23 | Traditional | PDF ↗ |
| K211530 | PathBuilder Steerable Introducer | Shanghai Microport EP Medtech Co., Ltd. | 2022-02-08 | Traditional | PDF ↗ |
| K220047 | AcQCross Qx Integrated Transseptal Dilator/Needle | Acutus Medical, Inc. | 2022-02-08 | Traditional | PDF ↗ |
| K212152 | Prelude IDeal 9F Hydrophilic Sheath Introducer | Merit Medical Systems | 2022-01-07 | Traditional | PDF ↗ |
| K213638 | Traveler 0.038 Stylet Portal Vein Access (TPS001), Traveler 21ga Needle Portal Vein Access Set (TPS002), Traveler 16ga Needle Portal Vein Access Set (TPS003) | Argon Medical Devices | 2021-12-10 | Special | PDF ↗ |
| K213002 | SCORPION Portal Vein Access Set | Argon Medical Devices | 2021-10-14 | Special | PDF ↗ |
| K211405 | Prelude Guide Sheath | Merit Medical Systems, Inc. | 2021-10-04 | Traditional | PDF ↗ |
| K212708 | Halo One Thin-Walled Guiding Sheath | C.R. Bard, Inc. | 2021-09-23 | Special | PDF ↗ |
| K211989 | Aveir Introducer | ABBOTT MEDICAL | 2021-07-27 | Special | PDF ↗ |
| K210185 | CardioCurve Steerable Sheath | Talon Surgical | 2021-07-23 | Traditional | PDF ↗ |
| K203459 | SafeCross Transseptal Puncture and Introducer (TSP/I) System | East End Medical I, LLC | 2021-07-06 | Traditional | PDF ↗ |
| K210627 | Breezeway II | Oscor, Inc. | 2021-06-03 | Special | PDF ↗ |
| K210685 | AcQCross Qx Integrated Transseptal Dilator/Needle | Acutus Medical, Inc. | 2021-04-06 | Traditional | PDF ↗ |
| K202167 | Brite Tip Radianz Guiding Sheath | Cordis Corporation | 2021-02-26 | Traditional | PDF ↗ |
| K203670 | Extra Large Check-Flo Introducer | Cook Incorporated | 2021-02-16 | Traditional | PDF ↗ |
| K202141 | Scorpion Stylet Portal Vein Access Set, Scorpion Needle Portal Vein Access Set | Argon Medical Devices, Inc. | 2021-01-15 | Traditional | PDF ↗ |
| K201489 | Traveler38 0.038 Stylet Portal Vein Access Set, Traveler21 21ga Needle Portal Vein Access Set, Traveler16 16ga Needle Portal Vein Access set | Argon Medical Devices, Inc. | 2020-12-22 | Traditional | PDF ↗ |
| K202226 | Lim Precision Steerable TS, Steerable Sheath, Dilator | Keystone Heart, Ltd. | 2020-12-15 | Traditional | PDF ↗ |
| K202330 | Impella XR Sheath Set | Abiomed, Inc. | 2020-12-07 | Traditional | PDF ↗ |
| K203179 | Fortress Introducer Sheath System | Contract Medical International, GmbH | 2020-11-20 | Special | PDF ↗ |
| K202584 | iSleeve Introducer Set | Boston Scientific Corporation | 2020-10-06 | Special | PDF ↗ |
| K201116 | Abiomed 23 Fr Sheath | Abiomed, Inc. | 2020-06-15 | Traditional | PDF ↗ |
| K200258 | Edwards eSheath Introducer Set | Edwards Lifesciences | 2020-03-09 | Traditional | PDF ↗ |
| K193509 | AcQGuide Flex with AcQCross QX, AcQGuide Mini with AcQCross QX | Acutus Medical, Inc. | 2020-01-17 | Traditional | PDF ↗ |
| K193125 | R2P Destination Slender Guiding Sheath | Terumo Medical Corporation | 2020-01-06 | Traditional | PDF ↗ |
| K192313 | Halo One Thin-Walled Guiding Sheath | C.R. Bard, Inc. | 2019-12-19 | Traditional | PDF ↗ |
Product code DYB · Class II · Cardiovascular. Data: openFDA.