510(k) K021591 ยท KRA Catheter, Continuous Flush
PROWLER SELECT (10, 14, AND PLUS) INFUSION CATHETERS WITH AND WITHOUT PRE-SHAPED TIPS
| Applicant | Cordis Neurovascular, Inc., Miami Lake FL, US |
| Decision | Substantially Equivalent, May 22, 2002 |
| Received | May 15, 2002 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K021591
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 2, 2006 | Cordis Neurovascular, Inc. Cordis Neurovascular Pre-Shaped PROWLER Infusion Catheters. Terminated |
KRA | None listed |
| Sep 2, 2006 | Cordis Neurovascular, Inc. Cordis Neurovascular Pre-Shaped Prowler Select Infusion Catheters. Terminated |
KRA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.