510(k) K893188 ยท MPB Catheter, Hemodialysis, Non-Implanted
QUINTON SINGLE LUMEN CATHETER
| Applicant | Quinton, Inc., Bothell WA, US |
| Decision | Substantially Equivalent, Jun 8, 1989 |
| Received | May 5, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K893188
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 29, 2019 | COVIDIEN LLC MAHURKAR and Argyle acute hemodialysis catheters, Material numbers 8813793009
8813793013
8813794005
8813794009
8813816005
8813816009
8813817005
8813817009
8815668007
8815668011
8815668021
8815668027
8 Terminated |
NIE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.