510(k) K051997 ยท DTZ Oxygenator, Cardiopulmonary Bypass
CAPIOX RX15 HOLLOW, FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIR
| Applicant | Terumo Cardiovascular Systems Corp., Elkton MD, US |
| Decision | Substantially Equivalent, Sep 15, 2005 |
| Received | Jul 25, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K051997
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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.