510(k) K202672 ยท FPA Set, Administration, Intravascular
Precision Delivery Infusion Set
| Applicant | Quest Medical, Inc., Allen TX, US |
| Decision | Substantially Equivalent, Jan 21, 2021 |
| Received | Sep 15, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K202672
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 7, 2023 | Quest Medical, Inc. Precision Delivery Set with Filter, REF: PD06F; and Precision Delivery Set with Trifurcated Luer, REF: PDT05CV2 Open, Classified |
FPA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.