FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
POLYFLEX STENT SYSTEM WITH DELIVERY SYSTEM, MODEL M00514270, M00514280, 00514290, 00514300, 00514310, 00514320, 00514330
K Number: K080332
·
Decision Sep 5, 2008
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
58
Applicant Total
231
Review Days
211
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Basic Information
- Device Name
- POLYFLEX STENT SYSTEM WITH DELIVERY SYSTEM, MODEL M00514270, M00514280, 00514290, 00514300, 00514310, 00514320, 00514330
- K Number
- K080332
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.3610
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Boston Scientific Corporation
- Date Received
- February 7, 2008
- Decision Date
- September 5, 2008
- Product Code
- ESW
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| ESW | Prosthesis, Esophageal | FDA class 2 | General, Plastic Surgery |
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