510(k) K060016 ยท MCW Catheter, Peripheral, Atherectomy
THROMCAT THROMBECTOMY CATHETER SYSTEM
| Applicant | Kensey Nash Corp., Exton PA, US |
| Decision | Substantially Equivalent, Apr 25, 2006 |
| Received | Jan 3, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K060016
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 23, 2007 | Kensey Nash Corp ThromCat Thrombectomy Catheter System. Catalog number 63000-01 Terminated |
MCW | None listed |
| Mar 8, 2007 | Kensey Nash Corp ThromCat Thrombectomy Catheter System. 7F 2.5 -7.0 mm 150 cm. Catalogue number 63000-01. It is a single-use, disposable device that is used to perform percutaneous maceration and removal of thrombus Terminated |
MCW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.