510(k) K963248 ยท DYG Catheter, Flow Directed
FLOW DIRECTED THERMODILUTION/INFUSION BALLOON CATHETER (575-110P)
| Applicant | J-Lloyd Medical, Inc., West Berlin NJ, US |
| Decision | Substantially Equivalent, Feb 3, 1997 |
| Received | Aug 19, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K963248
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.