Panels › Cardiovascular › Product code JOR · Class 3
Generator, Pulsatile Flow, Cardiopulmonary Bypass
Regulation 870.4320
0510(k)s in 12 months (0 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in JOR
| Company | 510(k)s | Recalls |
|---|---|---|
| Terumo Cardiovascular Systems Corporation | 0 | 2 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 8, 2010 | Terumo Cardiovascular Systems Corporation Sarns 8000 Roller pump for Sarns System 8000 Heart Lung Machine console, 220V, Catalog No 16407, Terumo Cardiovascular System Corp Ann Arbor, MI. (not distributed in the US)
The system 8000 is indic Terminated |
JOR | K915183 |
| Dec 8, 2010 | Terumo Cardiovascular Systems Corporation Sarns 8000 Roller pump for Sarns System 8000 Heart Lung Machine console, 115V, Catalog No 16402, Terumo Cardiovascular System Corp Ann Arbor, MI.
The system 8000 is indicated for use in extracorpor Terminated |
JOR | K915183 |
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