Product code DYB
- Device name
- Introducer, Catheter
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation number
- 870.1340
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253526 | NAMIC Dilator and Sheath | Medline Industries, LP | 2026-07-29 |
| K261529 | Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit / Microintroducer Kit (SIS05C); Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set / Microintroducer Kit / Microint... | Hartman Medical Group, LLC | 2026-07-06 |
| K261242 | SimplGuide | Pendracare | 2026-06-25 |
| K261950 | Health Line Tearaway Introducer | Health Line International Corporation | 2026-06-22 |
| K261492 | FieldFlex Steerable Sheath | CenterPoint Systems, LLC | 2026-06-05 |
| K260606 | Echo Large Bore Introducer Sheath | Echo Medical, LLC | 2026-04-29 |
| K254248 | Introducer Sheath Set | Cardiocycle Medical(Suzhou) Co., Ltd. | 2026-04-23 |
| K254279 | Edwards eSheath+ introducer set | Edwards Lifesciences | 2026-04-17 |
| K260091 | Aventus Introducer Sheath | Inquis Medical | 2026-04-13 |
| K260839 | Protaryx Transseptal Puncture Device (PTX2-001) | Protaryx Medical, Inc. | 2026-04-10 |
| K260942 | AuST Steerable Sheath | CenterPoint Systems, LLC | 2026-04-07 |
| K260459 | VANES Delivery System (VDS) | Zoll Respicardia, Inc. | 2026-04-06 |
| K260626 | Multiflex Steerable Sheath 17.5F | Vizaramed, Inc. | 2026-03-26 |
| K260163 | AuST CSP Introducer | CenterPoint Systems, LLC | 2026-02-19 |
| K254236 | Peel-Away Introducer Sheath | VascuTech Medical, LLC | 2026-02-09 |
| K253652 | Genie MAX Large Bore Introducer Sheath | Cultiv8 1, LLC | 2026-01-22 |
| K252508 | Intri26 Introducer Sheath | Inari Medical, Inc. | 2025-12-17 |
| K253741 | V•Stick™ Vascular Access Set | Argon Medical Devices, Inc. | 2025-12-15 |
| K252309 | PerQseal Introducers | Vivasure Medical Limited | 2025-10-23 |
| K251838 | Introducer Sheath Set | Cardiocycle Medical(Suzhou) Co., Ltd. | 2025-10-21 |
| K252766 | 14Fr Low Profile Introducer Kit | Abiomed, Inc. | 2025-10-08 |
| K252441 | Primero Safe Access System | South53, LLC | 2025-09-29 |
| K252227 | Pounce(TM) Sheath | Surmodics,Inc. | 2025-09-24 |
| K252027 | Vertex(TM) Catheter | Jupiter Endovascular | 2025-09-12 |
| K252364 | Edwards eSheath Optima introducer set | Edwards Lifesciences | 2025-08-29 |
| K251051 | AuST Steerable Sheath | CenterPoint Systems, LLC | 2025-04-30 |
| K250909 | Prelude Wave Hydrophilic Sheath Introducer | Merit Medical Systems, Inc. | 2025-04-25 |
| K243954 | PeriCross™ Epicardial Access Kit | Circa Scientific, Inc. | 2025-04-24 |
| K244046 | Edwards eSheath Optima introducer set | Edwards Lifesciences | 2025-03-27 |
| K243928 | ViaOne Epicardial Access System | Cardiovia , Ltd. | 2025-03-20 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00733132658923 | GORE® DrySeal Flex Introducer Sheath | W. L. Gore & Associates, Inc. | 2024-12-02 |
| 00733132658855 | GORE® DrySeal Flex Introducer Sheath | W. L. Gore & Associates, Inc. | 2024-12-02 |
| 00733132658862 | GORE® DrySeal Flex Introducer Sheath | W. L. Gore & Associates, Inc. | 2024-12-02 |
| 00733132658879 | GORE® DrySeal Flex Introducer Sheath | W. L. Gore & Associates, Inc. | 2024-12-02 |
| 00733132658886 | GORE® DrySeal Flex Introducer Sheath | W. L. Gore & Associates, Inc. | 2024-12-02 |
| 00733132658893 | GORE® DrySeal Flex Introducer Sheath | W. L. Gore & Associates, Inc. | 2024-12-02 |
| 00733132658909 | GORE® DrySeal Flex Introducer Sheath | W. L. Gore & Associates, Inc. | 2024-12-02 |
| 00733132658916 | GORE® DrySeal Flex Introducer Sheath | W. L. Gore & Associates, Inc. | 2024-12-02 |
| 00733132629985 | GORE DRYSEAL FLEX Introducer Sheath | W. L. Gore & Associates, Inc. | 2023-05-25 |
| 00733132628346 | GORE DRYSEAL FLEX Introducer Sheath | W. L. Gore & Associates, Inc. | 2020-07-11 |
| 00733132628322 | GORE DRYSEAL FLEX Introducer Sheath | W. L. Gore & Associates, Inc. | 2020-07-11 |
| 00733132628308 | GORE DRYSEAL FLEX Introducer Sheath | W. L. Gore & Associates, Inc. | 2020-07-11 |
| 00733132628285 | GORE DRYSEAL FLEX Introducer Sheath | W. L. Gore & Associates, Inc. | 2020-07-11 |
| 00733132629978 | GORE DRYSEAL FLEX Introducer Sheath | W. L. Gore & Associates, Inc. | 2020-01-09 |
| 00733132628261 | GORE DRYSEAL FLEX Introducer Sheath | W. L. Gore & Associates, Inc. | 2020-01-09 |
| 00733132628094 | GORE DRYSEAL FLEX Introducer Sheath | W. L. Gore & Associates, Inc. | 2020-01-09 |
| 00733132630011 | GORE DRYSEAL FLEX Introducer Sheath | W. L. Gore & Associates, Inc. | 2016-07-22 |
| 00733132630950 | GORE DRYSEAL FLEX Introducer Sheath | W. L. Gore & Associates, Inc. | 2016-07-22 |
| 00733132630103 | GORE DRYSEAL FLEX Introducer Sheath | W. L. Gore & Associates, Inc. | 2016-07-22 |
| 00733132630073 | GORE DRYSEAL FLEX Introducer Sheath | W. L. Gore & Associates, Inc. | 2016-07-22 |
| 00733132630066 | GORE DRYSEAL FLEX Introducer Sheath | W. L. Gore & Associates, Inc. | 2016-07-22 |
| 00733132630042 | GORE DRYSEAL FLEX Introducer Sheath | W. L. Gore & Associates, Inc. | 2016-07-22 |
| 00733132630028 | GORE DRYSEAL FLEX Introducer Sheath | W. L. Gore & Associates, Inc. | 2016-07-22 |
| 00733132630004 | GORE DRYSEAL FLEX Introducer Sheath | W. L. Gore & Associates, Inc. | 2016-07-22 |
| 00733132629961 | GORE DRYSEAL FLEX Introducer Sheath | W. L. Gore & Associates, Inc. | 2016-07-22 |
| 00733132628421 | GORE DRYSEAL FLEX Introducer Sheath | W. L. Gore & Associates, Inc. | 2016-07-22 |
| 00733132628407 | GORE DRYSEAL FLEX Introducer Sheath | W. L. Gore & Associates, Inc. | 2016-07-22 |
| 00733132628384 | GORE DRYSEAL FLEX Introducer Sheath | W. L. Gore & Associates, Inc. | 2016-07-22 |
| 00733132628360 | GORE DRYSEAL FLEX Introducer Sheath | W. L. Gore & Associates, Inc. | 2016-07-22 |
| 00733132628117 | GORE DRYSEAL FLEX Introducer Sheath | W. L. Gore & Associates, Inc. | 2016-05-23 |