CPS Excel™ DS2M028
CPS Excel™ DS2M028 is a Class II device made by St. Jude Medical, Inc., cleared under FDA 510(k) K142254 on 13 Nov 2014 and listed in FDA GUDID since 17 Sep 2015 (UDI-DI 05414734505345), 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 | Number05414734505345 | Date17 Sep 2015 | StatusListed |
| United States | FDA 510(k)SESE | NumberK142254 | Date13 Nov 2014 | StatusActive |
Official records
- AccessGUDID record 05414734505345
- FDA 510(k) database K142254
Across registries
- FDA 510(k) K142254 decided 13 Nov 2014 Active
- FDA GUDID UDI-DI 05414734505345 listed 17 Sep 2015 Listed
Timeline
- Cleared FDA 510(k) K142254
- Listed FDA GUDID 05414734505345
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- CPS Excel™
- Generic name
- Cardiac/peripheral vascular guidewire, single-use
- Model / Ref / Catalog
- DS2M028
- Primary DI / UDI-DI
- 05414734505345
- 510(k) Number
- FDA product code
- DQX
- GMDN term
- Cardiac/peripheral vascular guidewire, single-use
- Device class
- Class II
- Regulation number
- 870.1330
- GUDID distribution status
- In Commercial Distribution
- Size
- Length — 195 Centimeter
Similar devices in this category
Other devices filed under Cardiac/peripheral vascular guidewire, single-use.