510(k) K173716 ยท DTR Heat-Exchanger, Cardiopulmonary Bypass
MPS2 Myocardial Protection System Console
| Applicant | Quest Medical, Inc., Allen TX, US |
| Decision | Substantially Equivalent, Oct 1, 2018 |
| Received | Dec 5, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K173716
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 17, 2019 | Quest Medical, Inc. Ref 801168, MPS Top Cover Replacement Kit, 1 UNITS, UDI: (01)2 0634624 81168 7 (11)190916 (17)290913 (10)059135
(The device is a component of the MPS Console used as replacements for worn or damaged Terminated |
DTR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.