510(k) K003925 ยท KRA Catheter, Continuous Flush
PROWLER INFUSION CATHETERS WITH PRE-SHAPED TIPS
| Applicant | Cordis Neurovascular, Inc., Miami Lake FL, US |
| Decision | Substantially Equivalent, Jan 8, 2001 |
| Received | Dec 20, 2000 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K003925
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 15, 2003 | Cordis Neurovascular, Inc. Product is labeled as Cordis Pre-shaped Prowler Plus MP Infusion Catheter (3 F proximal OD, 2.3 F Distal OD, 45 cm distal length, total length 155 cm) with an MP (45 degree) dual marker band tip. Als Terminated |
None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.