MODIFICATION TO: XCEED NITINOL SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM
FDA 510(k) clearance K050501 · decided 2005-03-14
Clearance details
- K-number
- K050501
- Device name
- MODIFICATION TO: XCEED NITINOL SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM
- Applicant
- Abbott Vascular Devices
- Decision
- Unknown
- Date received
- 2005-02-28
- Decision date
- 2005-03-14
- Days to decision
- 14 days
- Clearance type
- Special
- Product code
- FGE
- Device class
- 2
- Regulation number
- 876.5010
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Redwood, CA, 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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