510(k) K900815 ยท DTW Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass
SARNS 9000 PERFUSION SYSTEM W/ALERT ONLY LEVEL
| Applicant | 3M Company, Ann Arbor MI, US |
| Decision | Substantially Equivalent, May 9, 1990 |
| Received | Feb 21, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K900815
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 27, 2007 | Terumo Cardiovascular Systems Corp Terumo Perfusion System 8000 Base, 4 pump, 115v; Model 8000; Catalog No. 16400. Terminated |
DTW | None listed |
| Mar 27, 2007 | Terumo Cardiovascular Systems Corp Terumo Perfusion System 8000 Base, 5 pump, 115v; Model 8000; Catalog No. 16401. Terminated |
DTW | None listed |
| Mar 27, 2007 | Terumo Cardiovascular Systems Corp Terumo Perfusion System 8000 Base, 4 pump, 220/240v; Model 8000; Catalog No. 16405. Terminated |
DTW | None listed |
| Mar 27, 2007 | Terumo Cardiovascular Systems Corp Terumo Perfusion System 8000 Base, 5 pump, 220/240v; Model 8000; Catalog No. 16406. Terminated |
DTW | None listed |
| Mar 27, 2007 | Terumo Cardiovascular Systems Corp Terumo Perfusion System 8000 Base, 5 pump, 100v, Model 8000; Catalog No. 16410. Terminated |
DTW | None listed |
| Dec 7, 2006 | Terumo Cardiovascular Systems Corp Terumo Perfusion System 9000, 100v, with color screen; Model 9000; Catalog No. 164280. Terminated |
DTW | None listed |
| Dec 7, 2006 | Terumo Cardiovascular Systems Corp Terumo Perfusion System 9000, 220/240v, with color screen; Model 9000; Catalog No. 164290. Terminated |
DTW | None listed |
| Dec 7, 2006 | Terumo Cardiovascular Systems Corp Terumo Perfusion System 9000, 115v, with color screen; Model 9000; Catalog No. 164300. Terminated |
DTW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.