510(k) K032763 ยท QEZ Aspiration Thrombectomy Catheter
VASCULAR SOLUTIONS PRONTO EXTRACTION CATHETER
| Applicant | Vascular Solutions, Inc., Minneapolis MN, US |
| Decision | Substantially Equivalent, Dec 19, 2003 |
| Received | Sep 5, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K032763
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 20, 2004 | Vascular Solutions, Inc. The Pronto Extraction Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the arterial system. Terminated |
DXE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.