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 |
|---|
| 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 |
| K243954 | circa scientific | PeriCross Epicardial Access Kit | April 24, 2025 |
| K244046 | edwards lifesciences | Edwards eSheath Optima introducer set | March 27, 2025 |
| K250468 | boston scientific | iSLEEVE Introducer Set | March 20, 2025 |
| K243928 | cardiovia | ViaOne Epicardial Access System | March 20, 2025 |
| K250439 | contract medical international | Catapult Guide Sheath; 4F; 15cm (US-34015-F-ST-H); Catapult Guide Sheath; 4F; 45 | March 16, 2025 |
| K243493 | abbott medical | Agilis NxT Steerable Introducer Dual-Reach | December 13, 2024 |