LIFESTENT NT35 BILIARY STENT SYSTEM
FDA 510(k) clearance K042985 · decided 2004-12-23
Clearance details
- K-number
- K042985
- Device name
- LIFESTENT NT35 BILIARY STENT SYSTEM
- Applicant
- Edwards Lifesciences, LLC
- Decision
- Unknown
- Date received
- 2004-10-29
- Decision date
- 2004-12-23
- Days to decision
- 55 days
- Clearance type
- Special
- Product code
- FGE
- Device class
- 2
- Regulation number
- 876.5010
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.