Wholey™ WWES35001
Wholey™ WWES35001 is a Class II device made by Covidien LP, cleared under FDA 510(k) K120863 on 19 Apr 2012 and listed in FDA GUDID since 16 Jun 2017 (UDI-DI 00821684058725), 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 | Number00821684058725 | Date16 Jun 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK120863 | Date19 Apr 2012 | StatusActive |
Official records
- AccessGUDID record 00821684058725
- FDA 510(k) database K120863
Across registries
- FDA 510(k) K120863 decided 19 Apr 2012 Active
- FDA GUDID UDI-DI 00821684058725 listed 16 Jun 2017 Listed
Timeline
- Cleared FDA 510(k) K120863
- Listed FDA GUDID 00821684058725
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Wholey™
- Generic name
- Peripheral vascular guidewire extension
- Model / reference
- WWES35001
- Primary DI / UDI-DI
- 00821684058725
- 510(k) Number
- FDA product code
- DQX
- GMDN term
- Peripheral vascular guidewire extension
- Device class
- Class II
- Regulation number
- 870.1330
- GUDID distribution status
- In Commercial Distribution
- Size
- Length — 155 Centimeter
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