FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER
K Number: K141322
·
Decision Mar 27, 2015
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
44
Applicant Total
175
Review Days
311
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Basic Information
- Device Name
- ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER
- K Number
- K141322
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cook Incorporated
- Date Received
- May 20, 2014
- Decision Date
- March 27, 2015
- Product Code
- PNO
- 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 |
|---|---|---|---|
| PNO | Catheter, Percutaneous, Cutting/Scoring | FDA class 2 | Cardiovascular |
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FDA 510(k)
FDA Class 2
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