SUPERA INTERWOVEN SELF-EXPANDING BILIARY NITINOL STENT DELIVERY CATHETER, MODEL # S-04-040-120
FDA 510(k) clearance K071646 · decided 2008-01-31
Clearance details
- K-number
- K071646
- Device name
- SUPERA INTERWOVEN SELF-EXPANDING BILIARY NITINOL STENT DELIVERY CATHETER, MODEL # S-04-040-120
- Applicant
- Idev Technologies, Inc.
- Decision
- Unknown
- Date received
- 2007-06-18
- Decision date
- 2008-01-31
- Days to decision
- 227 days
- Clearance type
- Traditional
- Product code
- FGE
- Device class
- 2
- Regulation number
- 876.5010
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Houston, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.