ABSOLUTE .035 SELF-EXPANDING BILIARY STENT SYSTEM
FDA 510(k) clearance K033393 · decided 2003-11-10
Clearance details
- K-number
- K033393
- Device name
- ABSOLUTE .035 SELF-EXPANDING BILIARY STENT SYSTEM
- Applicant
- Guidant Corp.
- Decision
- Unknown
- Date received
- 2003-10-23
- Decision date
- 2003-11-10
- Days to decision
- 18 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 ABSOLUTE .035 Biliary Self-Expanding Stent System, 135 cm Length (Catheter), Base recall (Z-1080-06) | Guidant Endovascular Solutions, Inc. | 2006-06-07 |
| Guidant ABSOLUTE .035 Biliary Self-Expanding Stent System, 135 cm Length (Catheter), Base recall (Z-1082-06) | Guidant Endovascular Solutions, Inc. | 2006-06-07 |
| Guidant ABSOLUTE .035 Biliary Self-Expanding Stent System, 135 cm Length (Catheter), Base recall (Z-1083-06) | Guidant Endovascular Solutions, Inc. | 2006-06-07 |
| ABSOLUTE .035 Biliary Self-Expanding Stent System, 135 cm Length (Catheter)- Base Part #FG recall (Z-1084-06) | Guidant Endovascular Solutions, Inc. | 2006-06-07 |
| ABSOLUTE .035 Biliary Self-Expanding Stent System, 135 cm Length (Catheter), Base Part #FG recall (Z-1085-06) | Guidant Endovascular Solutions, Inc. | 2006-06-07 |