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 |
|---|---|---|---|
| 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 |
| K250468 | iSLEEVE Introducer Set | Boston Scientific | 2025-03-20 |
| 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 ... | Contract Medical International, GmbH | 2025-03-16 |
| K243493 | Agilis NxT Steerable Introducer Dual-Reach | ABBOTT MEDICAL | 2024-12-13 |
| K242520 | Element Vascular Access System | Penumbra, Inc. | 2024-11-20 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10884450119799 | Prelude EASE™ | Merit Medical Systems, Inc. | 2026-06-09 |
| 10884450114008 | Prelude IDeal™ | Merit Medical Systems, Inc. | 2026-06-09 |
| 10884450114855 | Prelude IDeal™ | Merit Medical Systems, Inc. | 2026-06-08 |
| 00850084947001 | Genie MAX | CULTIV8 1, LLC | 2026-05-29 |
| 08498840011782 | VYGON | Vygon Corporation | 2019-04-08 |
| 08498840011775 | VYGON | Vygon Corporation | 2019-04-08 |
| 08498840011768 | VYGON | Vygon Corporation | 2019-04-08 |
| 08498840011751 | VYGON | Vygon Corporation | 2019-04-08 |
| 08498840011317 | VYGON | Vygon Corporation | 2019-04-08 |
| 08498840011300 | VYGON | Vygon Corporation | 2019-04-08 |
| 07613327459234 | AXS VECTA 71 | Stryker Corporation | 2018-10-26 |
| 07613327459227 | AXS VECTA 71 | Stryker Corporation | 2018-10-26 |
| 07613327459210 | AXS VECTA 71 | Stryker Corporation | 2018-10-26 |
| 00813502010664 | Introducer Kit for Impella® | Oscor Inc. | 2017-11-30 |
| 00813502010237 | Introducer Kit for Impella® | Oscor Inc. | 2017-11-18 |
| 00813502010244 | Introducer Kit for Impella® | Oscor Inc. | 2017-11-18 |
| 00813502010558 | Introducer Kit for Impella® | Oscor Inc. | 2017-11-18 |
| 07613327115963 | NA | STRYKER CORPORATION | 2016-09-23 |
| 07613327115970 | NA | STRYKER CORPORATION | 2016-09-23 |
| 07613327116670 | NA | STRYKER CORPORATION | 2016-09-23 |
| 07613327115956 | NA | STRYKER CORPORATION | 2016-09-23 |
| 07613327115949 | NA | STRYKER CORPORATION | 2016-09-23 |
| 07613327115888 | NA | STRYKER CORPORATION | 2016-09-23 |
| 07613252722915 | NA | STRYKER CORPORATION | 2016-09-23 |
| 07613327115925 | NA | STRYKER CORPORATION | 2016-09-23 |
| 07613327115918 | NA | STRYKER CORPORATION | 2016-09-23 |
| 07613327115901 | NA | STRYKER CORPORATION | 2016-09-23 |
| 08498840000175 | VYGON | Vygon Corporation | 2016-08-18 |
| 07613327115932 | NA | STRYKER CORPORATION | 2016-01-29 |
| 07613327115895 | NA | STRYKER CORPORATION | 2016-01-29 |