PROTEGE GPS SELF-EXPANDING NITINOL STENT AND DELIVERY SYSTEM
FDA 510(k) clearance K033314 · decided 2003-11-21
Clearance details
- K-number
- K033314
- Device name
- PROTEGE GPS SELF-EXPANDING NITINOL STENT AND DELIVERY SYSTEM
- Applicant
- Ev3, Inc.
- Decision
- Unknown
- Date received
- 2003-10-15
- Decision date
- 2003-11-21
- Days to decision
- 37 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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