510(k) K192019 · DQO Catheter, Intravascular, Diagnostic
Dragonfly OpStar Imaging Catheter, AptiVue Software version E.5.1
| Applicant | ABBOTT MEDICAL, Westford MA, US |
| Decision | Substantially Equivalent, Nov 8, 2019 |
| Received | Jul 29, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192019
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 19, 2022 | Abbott Vascular Dragonfly OpStar Imaging Catheter, REF 1014651/1014652, 0.068 in, 0.014 in, 135 cm, STERILE EO Open, Classified |
DQO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.