Panels › Cardiovascular › Product code DTW · Class 2
Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass
Regulation 870.4340
0510(k)s in 12 months (17 all time)
0recalls in 12 months (15 all time)
15recalls that name a 510(k)
Top companies in DTW
| Company | 510(k)s | Recalls |
|---|---|---|
| Terumo Cardiovascular Systems Corp | 0 | 15 |
| 3M Health Care, Sarns | 2 | 0 |
| Gambro, Inc. | 2 | 0 |
| 3M Company | 1 | 0 |
| American Omni Medical, Inc. | 1 | 0 |
| Cobe Laboratories, Inc. | 1 | 0 |
| Jtl Medical Corp. | 1 | 0 |
| Medtronic, Inc. | 1 | 0 |
| R. Scott Bell | 1 | 0 |
| Respiratory Support Products, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 27, 2007 | Terumo Cardiovascular Systems Corp Terumo Perfusion System 8000 Base, 5 pump, 100v, Model 8000; Catalog No. 16410. Terminated |
DTW | K900815 |
| Mar 27, 2007 | Terumo Cardiovascular Systems Corp Terumo Perfusion System 8000 Base, 5 pump, 220/240v; Model 8000; Catalog No. 16406. Terminated |
DTW | K900815 |
| Mar 27, 2007 | Terumo Cardiovascular Systems Corp Terumo Perfusion System 8000 Base, 4 pump, 220/240v; Model 8000; Catalog No. 16405. Terminated |
DTW | K900815 |
| Mar 27, 2007 | Terumo Cardiovascular Systems Corp Terumo Perfusion System 8000 Base, 5 pump, 115v; Model 8000; Catalog No. 16401. Terminated |
DTW | K900815 |
| Mar 27, 2007 | Terumo Cardiovascular Systems Corp Terumo Perfusion System 8000 Base, 4 pump, 115v; Model 8000; Catalog No. 16400. Terminated |
DTW | K900815 |
| Dec 7, 2006 | Terumo Cardiovascular Systems Corp Manual Drive Unit for Sarns (Terumo) Centrifugal Perfusion System; Catalog No. 164268. Terminated |
DTW | K882758 |
| Dec 7, 2006 | Terumo Cardiovascular Systems Corp Terumo Perfusion System 8000 Base, 5 pump, 100v, Model 8000; Catalog No. 16410. Terminated |
DTW | K915183 |
| Dec 7, 2006 | Terumo Cardiovascular Systems Corp Terumo Perfusion System 8000 Base, 4 pump, 100v, Model 8000; Catalog No. 16409. Terminated |
DTW | K915183 |
| Dec 7, 2006 | Terumo Cardiovascular Systems Corp Terumo Perfusion System 8000 Base, 5 pump, 220240v; Model 8000; Catalog No. 16406. Terminated |
DTW | K915183 |
| Dec 7, 2006 | Terumo Cardiovascular Systems Corp Terumo Perfusion System 8000 Base, 4 pump, 220/240v; Model 8000; Catalog No. 16405. Terminated |
DTW | K915183 |
| Dec 7, 2006 | Terumo Cardiovascular Systems Corp Terumo Perfusion System 8000 Base, 5 pump, 115v; Model 8000; Catalog No. 16401. Terminated |
DTW | K915183 |
| Dec 7, 2006 | Terumo Cardiovascular Systems Corp Terumo Perfusion System 8000 Base, 4 pump, 115v; Model 8000; Catalog No. 16400. Terminated |
DTW | K915183 |
| Dec 7, 2006 | Terumo Cardiovascular Systems Corp Terumo Perfusion System 9000, 115v, with color screen; Model 9000; Catalog No. 164300. Terminated |
DTW | K900815 |
| Dec 7, 2006 | Terumo Cardiovascular Systems Corp Terumo Perfusion System 9000, 220/240v, with color screen; Model 9000; Catalog No. 164290. Terminated |
DTW | K900815 |
| Dec 7, 2006 | Terumo Cardiovascular Systems Corp Terumo Perfusion System 9000, 100v, with color screen; Model 9000; Catalog No. 164280. Terminated |
DTW | K900815 |
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