510(k) K072769 ยท QEZ Aspiration Thrombectomy Catheter
ANGIOJET ULTRA; XMI (105041), XVG (105042) AND SPIROFLEX (106553) THROMBECTOMY SETS
| Applicant | Possis Medical, Inc., Minneapolis MN, US |
| Decision | Substantially Equivalent, Nov 14, 2007 |
| Received | Sep 28, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K072769
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 13, 2015 | Boston Scientific Corporation AngioJet Spiroflex Thrombectomy Set: Peripheral - UPN 106553-004, Catalog No.106553, Sterilized Using Ethylene Oxide. For breaking apart and removing t Terminated |
DXE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.