Fast-Cath™ 406820
Fast-Cath 406820 is a vascular catheter introduction set (FDA Class II; FDA product code DYB, Introducer, Catheter) made by St. Jude Medical, Inc., cleared under FDA 510(k) K061015 on 3 Aug 2006 and listed in FDA GUDID since 6 Mar 2015 (UDI-DI 05414734202886), active as of 9 Nov 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number05414734202886 | Date6 Mar 2015 | StatusListed |
| United States | FDA 510(k)SESE | NumberK061015 | Date3 Aug 2006 | StatusActive |
Official records
- AccessGUDID record 05414734202886
- FDA 510(k) database K061015
Across registries
- FDA 510(k) K061015 decided 3 Aug 2006 Active
- FDA GUDID UDI-DI 05414734202886 listed 6 Mar 2015 Listed
Timeline
- Cleared FDA 510(k) K061015
- Listed FDA GUDID 05414734202886
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Fast-Cath™
- Generic name
- Vascular catheter introduction set, nonimplantable
- Model / Ref / Catalog
- 406820
- Primary DI / UDI-DI
- 05414734202886
- 510(k) Number
- FDA product code
- DYB
- GMDN term
- Vascular catheter introduction set, nonimplantable
- Device class
- Class II
- Regulation number
- 870.1340
- GUDID distribution status
- In Commercial Distribution
- Size
- Catheter Gauge — 8 FrenchLength — 60.0000 Centimeter
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