510(k) K113363 ยท QEZ Aspiration Thrombectomy Catheter
ANGIOJET SOLENT DISTA THROMBECTOMY SET
| Applicant | Medrad, Inc., Minneapolis MN, US |
| Decision | Substantially Equivalent, Jun 6, 2012 |
| Received | Nov 15, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K113363
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 13, 2015 | Boston Scientific Corporation AngioJet SOLENT Dista Thrombectomy Set: UPN 111303-001, Catalog No. 111303, Sterilized Using Ethylene Oxide. For breaking apart and removing thrombus f Terminated |
DXE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.