FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER
K Number: K121442
·
Decision Jun 14, 2012
Classifications
1
FEI Numbers
92
Registration Numbers
92
Same Product Code
402
Applicant Total
13
Review Days
30
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Basic Information
- Device Name
- POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER
- K Number
- K121442
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cordis Corporation
- Date Received
- May 15, 2012
- Decision Date
- June 14, 2012
- Product Code
- LIT
- 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 |
|---|---|---|---|
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | FDA class 2 | Cardiovascular |
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