510(k) K993772 ยท DTZ Oxygenator, Cardiopulmonary Bypass
X-COATED CAPIOX SX18 AND SX25 HOLLOW FIBER OXYGENATOR WITH/ WITHOUT DETACHABLE HARDSHELL RESERVOIR
| Applicant | Terumo Medical Corp., Elkton MD, US |
| Decision | Substantially Equivalent, Jun 5, 2000 |
| Received | Nov 8, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K993772
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 24, 2012 | Terumo Cardiovascular Corporation Terumo Cardiovascular Systems CAPIOX (r) SX18 Hollow Fiber Oxygenator LOT: HF22 . 2010-04 The X-coated Capiox SX18 Hollow Fiber Oxygenators with Detachable Hardshell Reservoir are used to exchange gas Terminated |
DTZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.