100MM WALLSTENT RX BILIARY ENDOPROSTHESIS, MODELS M00569800 8MM, M00569810 10MM
FDA 510(k) clearance K030107 · decided 2003-03-21
Clearance details
- K-number
- K030107
- Device name
- 100MM WALLSTENT RX BILIARY ENDOPROSTHESIS, MODELS M00569800 8MM, M00569810 10MM
- Applicant
- Boston Scientific Corp
- Decision
- Unknown
- Date received
- 2003-01-13
- Decision date
- 2003-03-21
- Days to decision
- 67 days
- Clearance type
- Special
- Product code
- FGE
- Device class
- 2
- Regulation number
- 876.5010
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Natick,, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Wallstent Rx Biliary Endoprosthesis with Unistep Plus Delivery System 8 Fr, 10mm x 60mm Ca recall (Z-0563-04) | Boston Scientific Corporation | 2004-07-20 |