DYB — Introducer, Catheter Class II
FDA Device Classification
Classification Details
- Product Code
- DYB
- Device Class
- Class II
- Regulation Number
- 870.1340
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K254279 | edwards lifesciences | Edwards eSheath+ introducer set | April 17, 2026 |
| K260091 | inquis medical | Aventus Introducer Sheath | April 13, 2026 |
| K260839 | protaryx medical | Protaryx Transseptal Puncture Device (PTX2-001) | April 10, 2026 |
| K260942 | centerpoint systems | AuST Steerable Sheath | April 7, 2026 |
| K260459 | zoll respicardia | VANES Delivery System (VDS) | April 6, 2026 |
| K260626 | vizaramed | Multiflex Steerable Sheath 17.5F | March 26, 2026 |
| K260163 | centerpoint systems | AuST CSP Introducer | February 19, 2026 |
| K254236 | vascutech medical | Peel-Away Introducer Sheath | February 9, 2026 |
| K253652 | cultiv8 1 | Genie MAX Large Bore Introducer Sheath | January 22, 2026 |
| K252508 | inari medical | Intri26 Introducer Sheath | December 17, 2025 |
| K253741 | argon medical devices | VStick Vascular Access Set | December 15, 2025 |
| K252309 | vivasure medical limited | PerQseal Introducers | October 23, 2025 |
| K251838 | cardiocycle medical(suzhou) co | Introducer Sheath Set | October 21, 2025 |
| K252766 | abiomed | 14Fr Low Profile Introducer Kit | October 8, 2025 |
| K252441 | south53 | Primero Safe Access System | September 29, 2025 |
| K252227 | surmodics | Pounce(TM) Sheath | September 24, 2025 |
| K252027 | jupiter endovascular | Vertex(TM) Catheter | September 12, 2025 |
| K252364 | edwards lifesciences | Edwards eSheath Optima introducer set | August 29, 2025 |
| K251051 | centerpoint systems | AuST Steerable Sheath | April 30, 2025 |
| K250909 | merit medical systems | Prelude Wave Hydrophilic Sheath Introducer | April 25, 2025 |