FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
LIFESTENT BILIARY STENT SYSTEM, LIFESTENT XL BILIARY STENT SYSTEM
K Number: K130792
·
Decision Aug 30, 2013
Classifications
1
FEI Numbers
137
Registration Numbers
137
Same Product Code
464
Applicant Total
566
Review Days
161
Basic Information
- Device Name
- LIFESTENT BILIARY STENT SYSTEM, LIFESTENT XL BILIARY STENT SYSTEM
- K Number
- K130792
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5010
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Unknown
- Statement or Summary
- Summary
- Applicant
- C.R. BARD, INC.
- Date Received
- March 22, 2013
- Decision Date
- August 30, 2013
- Product Code
- FGE
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FGE | Stents, Drains And Dilators For The Biliary Ducts | FDA class 2 | Gastroenterology, Urology |
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