SUPERA VERITAS INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPTIC BILIARY SYSTEMS
FDA 510(k) clearance K111766 · decided 2011-10-19
Clearance details
- K-number
- K111766
- Device name
- SUPERA VERITAS INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPTIC BILIARY SYSTEMS
- Applicant
- Idev Technologies, Inc.
- Decision
- Unknown
- Date received
- 2011-06-23
- Decision date
- 2011-10-19
- Days to decision
- 118 days
- Clearance type
- Traditional
- Product code
- FGE
- Device class
- 2
- Regulation number
- 876.5010
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Webster, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| IDEV Technologies SUPERA VERITAS Interwoven Self-Expanding Nitinol Stent Transhepatic Bili recall (Z-1550-2013) | IDEV Technologies, Inc. | 2013-06-18 |