510(k) K953904 ยท DWB Pump, Blood, Cardiopulmonary Bypass, Roller Type
SARNS 9000 UNIVERSAL ROLLER PUMP
| Applicant | 3M Health Care, Ltd., Ann Arbor MI, US |
| Decision | Substantially Equivalent, Apr 19, 1996 |
| Received | Aug 18, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K953904
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 7, 2007 | Terumo Cardiovascular Systems Corp Terumo Perfusion System 8000 Roller Pump, 115V; Model 8000; Catalog No. 16402. Terminated |
DTQ | None listed |
| Jul 7, 2007 | Terumo Cardiovascular Systems Corp Terumo Perfusion System 8000 Roller Pump, 220/240V; Model 8000; Catalog No. 16407. Terminated |
DTQ | None listed |
| Jul 7, 2007 | Terumo Cardiovascular Systems Corp Terumo Perfusion System 9000 Roller Pump; Model 9000; Catalog No. 16395. Terminated |
DTQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.