510(k) K001063 ยท DYG Catheter, Flow Directed
SWAN-GANZ SYNTHETIC CONTROLCATH THERMODILUTION CATHETERS, MODELS C146F7, C146HF7, S146F7, S146HF7
| Applicant | Baxter Healthcare Corp, Irvine CA, US |
| Decision | Substantially Equivalent, Jul 7, 2000 |
| Received | Apr 3, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K001063
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.