FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFICATION TO HEMASHIELD PLATINUM WOVEN/MICROVEL DOUBLE VELOUR VASCULAR GRAFTS
K Number: K021213
·
Decision Apr 19, 2002
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
5
Applicant Total
432
Review Days
2
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Basic Information
- Device Name
- MODIFICATION TO HEMASHIELD PLATINUM WOVEN/MICROVEL DOUBLE VELOUR VASCULAR GRAFTS
- K Number
- K021213
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.3450
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Boston Scientific Corp
- Date Received
- April 17, 2002
- Decision Date
- April 19, 2002
- Product Code
- MAL
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| MAL | Graft, Vascular, Synthetic/Biologic Composite | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MAL), ordered by most recent decision date.
HEMASHIELD WOVEN DOUBLE VELOUR VASCULAR GRAFT MODEL M00202175XXXXX; M00202166XXXXX
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HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR TAAA GRAFT CONFIGURATION
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HEMASHIELD MICROVEL VELOUR KNITTED VASCULAR GRAFT
FDA 510(k)
FDA Class 2
·Cardiovascular
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