510(k) K111182 ยท QEZ Aspiration Thrombectomy Catheter
ANGIOJET SOLENT OMNI THROMBECTOMY SET
| Applicant | Medrad, Inc., Minneapolis MN, US |
| Decision | Substantially Equivalent, May 24, 2011 |
| Received | Apr 27, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K111182
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 13, 2015 | Boston Scientific Corporation AngioJet SOLENT Omni Thrombectomy Set: UPN 109681-004 & 109681-001, Catalog No 109681, Sterilized. For breaking apart and removing thrombus from vascu Terminated |
DXE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.