DYB
- Product code
- DYB
- Device name
- Introducer, Catheter
- Device class
- Class 2
- 21 CFR
- 21 CFR 870.1340
- Medical specialty
- Cardiovascular
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 57
- Summaries archived here
- 48 (direct download)
- 510(k) clearances (all years, FDA)
- 706 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (57)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K253526 | 2026-07-29 | Medline Industries, LP | NAMIC Dilator and Sheath | |
| K261529 | 2026-07-06 | Hartman Medical Group, LLC | Micropuncture Kit / Micropuncture Access Kit / Micro | |
| K261242 | 2026-06-25 | Pendracare | SimplGuide | |
| K261950 | 2026-06-22 | Health Line International Corporation | Health Line Tearaway Introducer | |
| K261492 | 2026-06-05 | CenterPoint Systems, LLC | FieldFlex Steerable Sheath | |
| K260606 | 2026-04-29 | Echo Medical, LLC | Echo Large Bore Introducer Sheath | |
| K254248 | 2026-04-23 | Cardiocycle Medical(Suzhou) Co., Ltd. | Introducer Sheath Set | |
| K254279 | 2026-04-17 | Edwards Lifesciences | Edwards eSheath+ introducer set | FDA |
| K260091 | 2026-04-13 | Inquis Medical | Aventus Introducer Sheath | |
| K260839 | 2026-04-10 | Protaryx Medical, Inc. | Protaryx Transseptal Puncture Device (PTX2-001) | FDA |
| K260942 | 2026-04-07 | CenterPoint Systems, LLC | AuST Steerable Sheath | |
| K260459 | 2026-04-06 | Zoll Respicardia, Inc. | VANES Delivery System (VDS) | |
| K260626 | 2026-03-26 | Vizaramed, Inc. | Multiflex Steerable Sheath 17.5F | |
| K260163 | 2026-02-19 | CenterPoint Systems, LLC | AuST CSP Introducer | |
| K254236 | 2026-02-09 | VascuTech Medical, LLC | Peel-Away Introducer Sheath | |
| K253652 | 2026-01-22 | Cultiv8 1, LLC | Genie MAX Large Bore Introducer Sheath | |
| K252508 | 2025-12-17 | Inari Medical, Inc. | Intri26 Introducer Sheath | |
| K253741 | 2025-12-15 | Argon Medical Devices, Inc. | VStick Vascular Access Set | |
| K252309 | 2025-10-23 | Vivasure Medical Limited | PerQseal Introducers | |
| K251838 | 2025-10-21 | Cardiocycle Medical(Suzhou) Co., Ltd. | Introducer Sheath Set | |
| K252766 | 2025-10-08 | Abiomed, Inc. | 14Fr Low Profile Introducer Kit | |
| K252441 | 2025-09-29 | South53, LLC | Primero Safe Access System | FDA |
| K252227 | 2025-09-24 | Surmodics,Inc. | Pounce(TM) Sheath | |
| K252027 | 2025-09-12 | Jupiter Endovascular | Vertex(TM) Catheter | |
| K252364 | 2025-08-29 | Edwards Lifesciences | Edwards eSheath Optima introducer set | |
| K251051 | 2025-04-30 | CenterPoint Systems, LLC | AuST Steerable Sheath | |
| K250909 | 2025-04-25 | Merit Medical Systems, Inc. | Prelude Wave Hydrophilic Sheath Introducer | |
| K243954 | 2025-04-24 | Circa Scientific, Inc. | PeriCross Epicardial Access Kit | |
| K244046 | 2025-03-27 | Edwards Lifesciences | Edwards eSheath Optima introducer set | |
| K250468 | 2025-03-20 | Boston Scientific | iSLEEVE Introducer Set | |
| K243928 | 2025-03-20 | Cardiovia , Ltd. | ViaOne Epicardial Access System | |
| K250439 | 2025-03-16 | Contract Medical International, GmbH | Catapult Guide Sheath; 4F; 15cm (US-34015-F-ST-H); C | |
| K243493 | 2024-12-13 | ABBOTT MEDICAL | Agilis NxT Steerable Introducer Dual-Reach | |
| K242520 | 2024-11-20 | Penumbra, Inc. | Element Vascular Access System | |
| K242756 | 2024-11-08 | Pulnovo Medical (Wuxi) Co., Ltd. | Introducer Sheath (PFlexi00L065, PFlexi00L070, PFlex | |
| K243061 | 2024-11-04 | Sonostik, LLC | SonoStik Guide Wire Introducer | |
| K242106 | 2024-10-04 | CenterPoint Systems, LLC | AuST Steerable Sheath | |
| K241230 | 2024-09-17 | Togo Medikit Co., Ltd. | Super Sheath Introducer Sheath S-3N5/1005 S-3N7/1006 | |
| K240600 | 2024-09-06 | East End Medical I, LLC | SafeCross Vascular Introducer System (4001) | |
| K242169 | 2024-08-23 | Biocardia | Morph DNA Steerable Introducer Sheath | |
| K242248 | 2024-08-22 | Beijing Demax Medical Technology Co.,L | Introducer Sheath Kits | — |
| K240957 | 2024-08-14 | Contract Medical International, GmbH | Catapult Guide Sheath | |
| K241708 | 2024-08-06 | Abiomed, Inc. | Abiomed 14Fr Low Profile Introducer Kit | |
| K241145 | 2024-08-01 | Argon Medical Devices, Inc. | TLAB® Transvenous Liver Biopsy System (TF-18C) | FDA |
| K241370 | 2024-06-13 | ABBOTT MEDICAL | Agilis NxT Steerable Introducer Dual-Reach (I-V2-M | |
| K240829 | 2024-05-01 | CenterPoint Systems, LLC | AuST Steerable Sheath | FDA |
| K240589 | 2024-03-25 | Cook Medical | Micropuncture Introducer Sets; Micropuncture Pedal A | |
| K233708 | 2024-02-16 | Synaptic Medical Corporation | NaviGo 12F Steerable Intracardiac Catheter Introduce | |
| K233959 | 2024-02-13 | AtriCure, Inc. | EPi-Ease Epicardial Access Device (EAS) | FDA |
| K240004 | 2024-01-31 | Circa Scientific, Inc. | CardioCurve Steerable Sheath Small Curl, 40cm (CC-10 | |
| K231227 | 2023-12-20 | Baylis Medical Company, Inc. | SureFlex HD Steerable Sheath, VersaCross HD Steerabl | FDA |
| K233691 | 2023-12-17 | Acutus Medical, Inc. | FlexCath Cross Transseptal Solution | |
| K233646 | 2023-12-12 | Inari Medical, Inc. | Intri24 Introducer Sheath (52-101) | |
| K233432 | 2023-12-08 | Argon Medical Devices, Inc. | 10F Sheath and Dilator Set | |
| K233503 | 2023-11-30 | Boston Scientific Corporation | 14F iSLEEVE Introducer Set | FDA |
| K232260 | 2023-09-27 | Inneuroco, Inc. | Thinline Sheath Introducer | |
| K231108 | 2023-09-27 | Inari Medical, Inc. | Talon Transseptal Sheath |
Official FDA classification page: DYB
Classification and pathway per current FDA publications. Data from openFDA (CC0).