WALLFLEX BILIARY RX FULLY-COVERED STENT SYSTEM, MODEL M00570500,M00570510, M00570520, M00570530, M00570540
FDA 510(k) clearance K083627 · decided 2009-04-07
Clearance details
- K-number
- K083627
- Device name
- WALLFLEX BILIARY RX FULLY-COVERED STENT SYSTEM, MODEL M00570500,M00570510, M00570520, M00570530, M00570540
- Applicant
- Boston Scientific Corporation
- Decision
- Unknown
- Date received
- 2008-12-08
- Decision date
- 2009-04-07
- Days to decision
- 120 days
- Clearance type
- Traditional
- Product code
- FGE
- Device class
- 2
- Regulation number
- 876.5010
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Marlboro, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
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