510(k) K101354 ยท QEZ Aspiration Thrombectomy Catheter
FETCH 2 ASPIRATION CATHETER MODEL 109400-001
| Applicant | Medrad Interventional/Possis, Minneapolis MN, US |
| Decision | Substantially Equivalent, Jan 21, 2011 |
| Received | May 14, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K101354
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 18, 2016 | Boston Scientific Corporation Boston Scientific Fetch 2 Aspiration Catheter, Catalog No. 109400-001.
Product The Fetch 2 Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the per Terminated |
DXE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.