510(k) K151791 ยท DTZ Oxygenator, Cardiopulmonary Bypass
Terumo Capiox FX15 Advance Oxygenator with Integrated Arterial Filter and Reservoir, Terumo Capiox FX25 Advance Oxygenator with Integrated Arterial Filter and Reservoir
| Applicant | Terumo Cardiovascular Systems Corporation, Elkton MD, US |
| Decision | Substantially Equivalent, Nov 19, 2015 |
| Received | Jul 1, 2015 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K151791
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 5, 2023 | Terumo Cardiovascular Systems Corporation CAPIOX FX25 Hollow Fiber Oxygenator, Catalog Numbers 3CX*FX25REC, 3CX*FX25RWC Open, Classified |
DTZ | None listed |
| Nov 11, 2020 | Terumo Cardiovascular Systems Corporation (1) Capiox FX25 (West) Advance Oxygenator- with left port, 4-liter Reservoir, XC modified to Advance, Sterile
Catalog Number: 3CX*FX25RWC
(2) Capiox FX25 (East) Advance Oxygenator - FX25 with right Terminated |
DTZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.