PROTEGE GPS SELF-EXPANDING NITINOL STENT
FDA 510(k) clearance K050725 · decided 2005-04-20
Clearance details
- K-number
- K050725
- Device name
- PROTEGE GPS SELF-EXPANDING NITINOL STENT
- Applicant
- Ev3 Corporation
- Decision
- Substantially Equivalent
- Date received
- 2005-03-21
- Decision date
- 2005-04-20
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- FGE
- Device class
- 2
- Regulation number
- 876.5010
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Plymouth, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ev3 Inc. 4600 Nathan Lane, Plymouth, MN Protg " GPS" Self-Expanding Biliary Stent System, recall (Z-0626-2011) | Ev3, Inc. | 2010-12-16 |