510(k) K192267 ยท DQO Catheter, Intravascular, Diagnostic
ILUMIEN System with AptiVue Software version D.3
| Applicant | ABBOTT MEDICAL, Westford MA, US |
| Decision | Substantially Equivalent, Dec 17, 2019 |
| Received | Aug 21, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K192267
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.