THROMCAT THROMBECTOMY CATHETER SYSTEM
FDA 510(k) clearance K060016 · decided 2006-04-25
Clearance details
- K-number
- K060016
- Device name
- THROMCAT THROMBECTOMY CATHETER SYSTEM
- Applicant
- Kensey Nash Corp.
- Decision
- Substantially Equivalent
- Date received
- 2006-01-03
- Decision date
- 2006-04-25
- Days to decision
- 112 days
- Clearance type
- Traditional
- Product code
- MCW
- Device class
- 2
- Regulation number
- 870.4875
- 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 |
|---|---|---|
| ThromCat Thrombectomy Catheter System. Catalog number 63000-01 recall (Z-1115-2007) | Kensey Nash Corp | 2007-07-23 |
| ThromCat Thrombectomy Catheter System. 7F 2.5 -7.0 mm 150 cm. Catalogue number 63000-01. I recall (Z-0597-2007) | Kensey Nash Corp | 2007-03-08 |