510(k) K911710 ยท DQO Catheter, Intravascular, Diagnostic
HEPARIN COATED THERMODILUTION CATH & ACCESSORIES
| Applicant | Sunscope Intl., Inc., Westlake Village CA, US |
| Decision | Substantially Equivalent, Oct 23, 1991 |
| Received | Apr 17, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K911710
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.