510(k) K103405 ยท QEZ Aspiration Thrombectomy Catheter
PRONTO V4 EXTRACTION CATHETER 5.5F; PRONTO V4 EXTRACTION CATHETER 6F; PRONTO V4 EXTRACTION 7F; PRONTO V4 EXTRACTION CATH
| Applicant | Vascular Solutions, Inc., Minneapolis MN, US |
| Decision | Substantially Equivalent, Dec 22, 2010 |
| Received | Nov 19, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K103405
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 4, 2011 | Vascular Solutions, Inc. Vascular Solutions, Pronto V4, Extraction Catheter, Sterilized using ethylene oxide, Rx Only. The following sizes/model numbers are affected: 5.5F( 4005), 6F(4006, 7F(4007, 8F(4008) are involved in t Terminated |
DXE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.