Panels › Cardiovascular › Product code KRL · Class 2
Detector, Bubble, Cardiopulmonary Bypass
Regulation 870.4205
0510(k)s in 12 months (14 all time)
0recalls in 12 months (4 all time)
3recalls that name a 510(k)
Top companies in KRL
| Company | 510(k)s | Recalls |
|---|---|---|
| Terumo Cardiovascular Systems | 1 | 4 |
| 3M Health Care, Sarns | 2 | 0 |
| Cobe Laboratories, Inc. | 2 | 0 |
| Rocky Mountain Research, Inc. | 2 | 0 |
| Sorin Biomedica, Fiat, USA, Inc. | 2 | 0 |
| Delta Medical Industries | 1 | 0 |
| Luna Innovations, Inc. | 1 | 0 |
| Shiley, Inc. | 1 | 0 |
| Sorin Group Deutschland GmbH | 1 | 0 |
| Terumo Medical Corp. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 8, 2010 | Terumo Cardiovascular Systems Corporation Air bubble detection cable assembly, catalog numbers 78-8067-7375-6 and 149892, Terumo Cardiovascular System, Ann Arbor, MI Terminated |
KRL | None listed |
| Jan 24, 2008 | Terumo Cardiovascular Systems Corp Terumo Ultrasonic air sensor, 1/4" by 3/32" (6.4 mm x 2.4 mm), Gold, for use on Terumo perfusion systems 1, 8000 and 9000; Catalog No: 5791, Terumo Cardiovascular Systems, Ann Arbor, MI 48103 Terminated |
KRL | K022947 |
| Jan 24, 2008 | Terumo Cardiovascular Systems Corp Terumo ultrasonic air sensor, 1/4" by 1/16" (6.4 mm x 1.6 mm), Black, for use on Terumo perfusion systems 1, 8000 and 9000; Catalog No: 5785, Terumo Cardiovalvular Systems, Ann Arbor, MI 48103 Terminated |
KRL | K022947 |
| Jan 24, 2008 | Terumo Cardiovascular Systems Corp Terumo Ultrasonic air sensor, 3/8" by 3/32" (9.5 mm x 2.4 mm), Red, for use on Terumo perfusion systems 1, 8000 and 9000; Catalog No: 5773, Terumo Cardiovascular Systems, Ann Arbor, MI 48103 Terminated |
KRL | K022947 |
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