OMNILINK .018 BILIARY STENT SYSTEM
FDA 510(k) clearance K033834 · decided 2004-01-02
Clearance details
- K-number
- K033834
- Device name
- OMNILINK .018 BILIARY STENT SYSTEM
- Applicant
- Guidant Corp.
- Decision
- Unknown
- Date received
- 2003-12-10
- Decision date
- 2004-01-02
- Days to decision
- 23 days
- Clearance type
- Special
- Product code
- FGE
- Device class
- 2
- Regulation number
- 876.5010
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Santa Clara, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Guidant OTW OMNILINK .018 & .035 Biliary Stent Systems recall (Z-1586-05) | Guidant Endovascular Solutions, Inc. | 2005-09-24 |