Cps Direct™ DS2C001
Cps Direct DS2C001 is a vascular guide-catheter (FDA Class II; FDA product code DQY, Catheter, Percutaneous) made by St. Jude Medical, Inc., cleared under FDA 510(k) K103250 on 19 Jan 2011 (1 earlier submission) and listed in FDA GUDID since 27 Jan 2017 (UDI-DI 05414734218191), 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 | Number05414734218191 | Date27 Jan 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK103250 | Date19 Jan 2011 | StatusActive |
Official records
- AccessGUDID record 05414734218191
- FDA 510(k) database K103250
- FDA 510(k) database K092075
Across registries
- FDA 510(k) K103250 decided 19 Jan 2011 Active
- FDA GUDID UDI-DI 05414734218191 listed 27 Jan 2017 Listed
Timeline
- Cleared FDA 510(k) K092075
- Cleared FDA 510(k) K103250
- Listed FDA GUDID 05414734218191
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Cps Direct™
- Generic name
- Vascular guide-catheter, single-use
- Model / Ref / Catalog
- DS2C001
- Primary DI / UDI-DI
- 05414734218191
- FDA product code
- DQY
- GMDN term
- Vascular guide-catheter, single-use
- Device class
- Class II
- Regulation number
- 870.1250
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
- Size
- Catheter Gauge — 9 FrenchLength — 47 Centimeter
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