MEDTRONIC, INC. RACER BILIARY STENT SYSTEM (RACER), MODEL XD#YF(L)
FDA 510(k) clearance K032768 · decided 2003-10-09
Clearance details
- K-number
- K032768
- Device name
- MEDTRONIC, INC. RACER BILIARY STENT SYSTEM (RACER), MODEL XD#YF(L)
- Applicant
- Medtronic Ave, Inc.
- Decision
- Unknown
- Date received
- 2003-09-08
- Decision date
- 2003-10-09
- Days to decision
- 31 days
- Clearance type
- Special
- Product code
- FGE
- Device class
- 2
- Regulation number
- 876.5010
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Santa Rosa, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Medtronic Racer Biliary Stent System, Model number XD518YF, UPC code 00721902758164 in a b recall (Z-1802-2010) | Medtronic CardioVascular | 2010-06-14 |