510(k) K180677 ยท DQO Catheter, Intravascular, Diagnostic
Surefire Spark Infusion System
| Applicant | Surefire Medical, Inc., Westminster CO, US |
| Decision | Substantially Equivalent, Apr 3, 2018 |
| Received | Mar 15, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180677
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.