EDWARDS LIFESCIENCES LIFESTENT NT18 SELF-EXPANDING BILIARY STENT AND DELIVERY SYSTEM
FDA 510(k) clearance K024303 · decided 2003-07-03
Clearance details
- K-number
- K024303
- Device name
- EDWARDS LIFESCIENCES LIFESTENT NT18 SELF-EXPANDING BILIARY STENT AND DELIVERY SYSTEM
- Applicant
- Edwards Lifesciences, LLC
- Decision
- Unknown
- Date received
- 2002-12-24
- Decision date
- 2003-07-03
- Days to decision
- 191 days
- Clearance type
- Traditional
- 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.