Detector, Bubble, Cardiopulmonary Bypass
FDA product code KRL · Class II (moderate risk) · 21 CFR 870.4205 · Cardiovascular
14510(k) clearances
0PMA approvals
4recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K103469 | Stockert Air Purge Control System Model 23-45-05KRL · Traditional | Sorin Group Deutschland GmbH | 01/18/2011SE |
| K090698 | Capiox Bubble Trap with X-CoatingKRL · Traditional | Terumo Cardiovascular Systems | 06/08/2009SE |
| K071231 | Edac QuantifierKRL · Traditional | Luna Innovations, Inc. | 05/17/2007SE |
| K961364 | Automatic Tubing Clamp System (Atc)KRL · Traditional | Rocky Mountain Research, Inc. | 10/31/1996SE |
| K961598 | Els Automatic Tubing Clamp SystemKRL · Traditional | Rocky Mountain Research, Inc. | 10/29/1996SE |
| K940651 | Sarns Ultrasonic Air SensorKRL · Traditional | 3M Health Care, Sarns | 05/24/1994SE |
| K935977 | Sarns Air Detection SystemKRL · Traditional | 3M Health Care, Sarns | 02/04/1994SE |
| K925661 | Stockert CAPS1 Cardioplegic Control ModuleKRL · Traditional | Sorin Biomedica, Fiat, USA, Inc. | 05/18/1993SE |
| K925541 | Stockert 1/4 Bubble SensorKRL · Traditional | Sorin Biomedica, Fiat, USA, Inc. | 02/02/1993SE |
| K911632 | Capiox(R) Bubble TrapKRL · Traditional | Terumo Medical Corp. | 07/09/1991SE |
| K864619 | Caps Low Level Detector & Detector/Bubble MonitorKRL · Traditional | Shiley, Inc. | 02/03/1987SE |
| K861860 | Cobe Accessory Interface Module (Aim)KRL · Traditional | Cobe Laboratories, Inc. | 07/18/1986SE |
| K842054 | Cobe AepsKRL · Traditional | Cobe Laboratories, Inc. | 08/02/1984SE |
| K803102 | Arterial Bubble Trap K-20KRL · Traditional | Delta Medical Industries | 12/22/1980SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0024-2011 | Air bubble detection cable assembly, catalog numbers 78-8067-7375-6 and 149892, Terumo…Malfunction of the air bubble detection cable assembly causes a false air alarm or a check sensor message… | Terumo Cardiovascular Systems Corporation | 10/15/2010Terminated |
| Z-0532-2008 | Terumo Ultrasonic air sensor, 1/4" by 3/32" (6.4 mm x 2.4 mm), Gold, for use on Terumo…False Alarm: The air sensor may malfunction and trigger false alarms, and may continue to alarm thus… | Terumo Cardiovascular Systems Corp | 09/19/2007Terminated |
| Z-0531-2008 | Terumo ultrasonic air sensor, 1/4" by 1/16" (6.4 mm x 1.6 mm), Black, for use on Terumo…False Alarm: The air sensor may malfunction and trigger false alarms, and may continue to alarm thus… | Terumo Cardiovascular Systems Corp | 09/19/2007Terminated |
| Z-0530-2008 | Terumo Ultrasonic air sensor, 3/8" by 3/32" (9.5 mm x 2.4 mm), Red, for use on Terumo…False Alarms: The air sensor may malfunction and trigger false alarms, and may continue to alarm thus… | Terumo Cardiovascular Systems Corp | 09/19/2007Terminated |