FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VASCUTRAK PTA DILATATION CATHETER
K Number: K103459
·
Decision Dec 13, 2010
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
44
Applicant Total
645
Review Days
19
Basic Information
- Device Name
- VASCUTRAK PTA DILATATION CATHETER
- K Number
- K103459
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- C.R. Bard, Inc.
- Date Received
- November 24, 2010
- Decision Date
- December 13, 2010
- Product Code
- PNO
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| PNO | Catheter, Percutaneous, Cutting/Scoring | FDA class 2 | Cardiovascular |
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FDA 510(k)
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