MODIFICATION TO PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY
FDA 510(k) clearance K023243 · decided 2002-12-13
Clearance details
- K-number
- K023243
- Device name
- MODIFICATION TO PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY
- Applicant
- Sulzer Intratherapeutics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-09-30
- Decision date
- 2002-12-13
- Days to decision
- 74 days
- Clearance type
- Special
- Product code
- FGE
- Device class
- 2
- Regulation number
- 876.5010
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Saint Paul, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Protg Self-Expanding Nitinol Stent 6 mm x 40 mm, Model Number SER6-6-40-135 recall (Z-0863-03) | ev3, Inc. | 2003-05-22 |