510(k) K180950 ยท DTZ Oxygenator, Cardiopulmonary Bypass
Terumo Capiox NX19 Oxygenator with Reservoir (east Orientation), Terumo Capiox NX19 Oxygenator with Reservoir (west Orientation), Terumo Capiox NX19 Oxygenator (east Orientation), Terumo Capiox NX19 Oxygenator (west Orientation)
| Applicant | Terumo Cardiovascular Systems Corporation, Elkton MD, US |
| Decision | Substantially Equivalent, Jun 22, 2018 |
| Received | Apr 11, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180950
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 5, 2023 | Terumo Cardiovascular Systems Corporation CAPIOX NX19 Hollow Fiber Oxygenator, Catalog Number 3CX*NX19RE Open, Classified |
DTZ | None listed |
| Jun 14, 2019 | Terumo Cardiovascular Systems Corporation Terumo Capiox NX19 Oxygenator With Reservoir (East Orientation)
P/N: 3CX*NX19RE Terminated |
DTZ | None listed |
| Jun 14, 2019 | Terumo Cardiovascular Systems Corporation Terumo Capiox NX19 Oxygenator With Reservoir (West Orientation)
P/N: 3CX*NX19RW Terminated |
DTZ | None listed |
| Jun 14, 2019 | Terumo Cardiovascular Systems Corporation Terumo Capiox NX19 Oxygenator (East Orientation), P/N: CXOT280
Exported only to Japan for inclusion into convenience kits that are sold only
within the Japanese market Terminated |
DTZ | None listed |
| Jun 14, 2019 | Terumo Cardiovascular Systems Corporation Terumo Capiox NX19 Oxygenator (West Orientation P/N:CXOT281
Exported only to Japan for inclusion into convenience kits that are sold only
within the Japanese market Terminated |
DTZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.