Fast-Cath™ 406840
Fast-Cath 406840 is a cardiac transseptal access 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 14 Apr 2015 (UDI-DI 05414734203340), active as of 23 Oct 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 | Number05414734203340 | Date14 Apr 2015 | StatusListed |
| United States | FDA 510(k)SESE | NumberK061015 | Date3 Aug 2006 | StatusActive |
Official records
- AccessGUDID record 05414734203340
- FDA 510(k) database K061015
Across registries
- FDA 510(k) K061015 decided 3 Aug 2006 Active
- FDA GUDID UDI-DI 05414734203340 listed 14 Apr 2015 Listed
Timeline
- Cleared FDA 510(k) K061015
- Listed FDA GUDID 05414734203340
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Fast-Cath™
- Generic name
- Cardiac transseptal access set
- Model / Ref / Catalog
- 406840
- Primary DI / UDI-DI
- 05414734203340
- 510(k) Number
- FDA product code
- DYB
- GMDN term
- Cardiac transseptal access set
- Device class
- Class II
- Regulation number
- 870.1340
- GUDID distribution status
- In Commercial Distribution
- Size
- Catheter Gauge — 8 FrenchLength — 63.0000 Centimeter
Similar devices in this category
Other devices filed under Cardiac transseptal access set.