POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER
FDA 510(k) clearance K121442 · decided 2012-06-14
Clearance details
- K-number
- K121442
- Device name
- POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER
- Applicant
- Cordis Corporation
- Decision
- Substantially Equivalent
- Date received
- 2012-05-15
- Decision date
- 2012-06-14
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- LIT
- Device class
- 2
- Regulation number
- 870.1250
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Bridgewater, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Cordis POWERFLEX PRO PTA Dilatation Catheter Intended to dilate stenoses in iliac, femoral recall (Z-0998-2015) | Cordis Corporation | 2015-01-16 |