XPERT SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM
FDA 510(k) clearance K050534 · decided 2005-05-20
Clearance details
- K-number
- K050534
- Device name
- XPERT SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM
- Applicant
- Abbott Laboratories
- Decision
- Unknown
- Date received
- 2005-03-02
- Decision date
- 2005-05-20
- Days to decision
- 79 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.
PMA approvals by this applicant
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|---|---|---|
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| ARCHITECT HBsAg Next Qualitative/Next Confirmatory, Alinity i HBsAg Next Qualitative/Next Confirmatory (P210003/S012) | Abbott Laboratories | 2024-09-30 |