510(k) K062381 ยท DTZ Oxygenator, Cardiopulmonary Bypass
CAPIOX RX OXYGENATOR WITH OR WITHOUT RESERVOIR
| Applicant | Terumo Cardiovascular Systems Corp., Elkton MD, US |
| Decision | Substantially Equivalent, Aug 24, 2006 |
| Received | Aug 15, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K062381
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 5, 2023 | Terumo Cardiovascular Systems Corporation CAPIOX RX15 Hollow Fiber Oxygenator, Catalog Number 3CX*RX15RE30 Open, Classified |
DTZ | None listed |
| May 11, 2012 | Terumo Cardiovascular Systems Corp Terumo Custom Cardiovascular Procedure Kit (manufactured to the design and specifications of the purchaser/user) for the application it is intended by the user.
X-COATED CHANGE OUT PACK WITH FX15 Terminated |
DTZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.