510(k) K192783 ยท DQX Wire, Guide, Catheter
Aristotle 24 Guidewire, 200cm, Soft Profile ; Aristotle 24 Guidewire, 200cm, Standard Profile ; Aristotle 24 Guidewire, 200cm, Support Profile
| Applicant | Scientia Vascular, LLC, West Valley City UT, US |
| Decision | Substantially Equivalent, Oct 30, 2019 |
| Received | Sep 30, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K192783
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.