QUICKCAT EXTRACTION CATHETER, MODEL 60090-01
FDA 510(k) clearance K073519 · decided 2008-03-28
Clearance details
- K-number
- K073519
- Device name
- QUICKCAT EXTRACTION CATHETER, MODEL 60090-01
- Applicant
- Kensey Nash Corp.
- Decision
- Substantially Equivalent
- Date received
- 2007-12-14
- Decision date
- 2008-03-28
- Days to decision
- 105 days
- Clearance type
- Special
- Product code
- QEZ
- Device class
- 2
- Regulation number
- 870.5150
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Exton, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Spectranetics Corporation, QuickCat Extraction Catheter, REF 60090-01, Sterile R, Working recall (Z-2190-2010) | Spectranetics Corporation | 2010-08-09 |