Product code KRL
- Device name
- Detector, Bubble, Cardiopulmonary Bypass
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation number
- 870.4205
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K103469 | STOCKERT AIR PURGE CONTROL SYSTEM MODEL 23-45-05 | Sorin Group Deutschland GmbH | 2011-01-18 |
| K090698 | CAPIOX BUBBLE TRAP WITH X-COATING | Terumo Cardiovascular Systems | 2009-06-08 |
| K071231 | EDAC QUANTIFIER | Luna Innovations, Inc. | 2007-05-17 |
| K961364 | AUTOMATIC TUBING CLAMP SYSTEM (ATC) | Rocky Mountain Research, Inc. | 1996-10-31 |
| K961598 | ELS AUTOMATIC TUBING CLAMP SYSTEM | Rocky Mountain Research, Inc. | 1996-10-29 |
| K940651 | SARNS ULTRASONIC AIR SENSOR | 3M Health Care, Sarns | 1994-05-24 |
| K935977 | SARNS AIR DETECTION SYSTEM | 3M Health Care, Sarns | 1994-02-04 |
| K925661 | STOCKERT CAPS1 CARDIOPLEGIC CONTROL MODULE | Sorin Biomedica, Fiat, USA, Inc. | 1993-05-18 |
| K925541 | STOCKERT 1/4 BUBBLE SENSOR | Sorin Biomedica, Fiat, USA, Inc. | 1993-02-02 |
| K911632 | CAPIOX(R) BUBBLE TRAP | Terumo Medical Corp. | 1991-07-09 |
| K864619 | CAPS LOW LEVEL DETECTOR & DETECTOR/BUBBLE MONITOR | Shiley, Inc. | 1987-02-03 |
| K861860 | COBE ACCESSORY INTERFACE MODULE (AIM) | Cobe Laboratories, Inc. | 1986-07-18 |
| K842054 | COBE AEPS | Cobe Laboratories, Inc. | 1984-08-02 |
| K803102 | ARTERIAL BUBBLE TRAP K-20 | Delta Medical Industries | 1980-12-22 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00886799000212 | Sarns™ Modular Perfusion System 8000 | Terumo Cardiovascular Systems Corporation | 2016-09-23 |
| 00886799000229 | Sarns™ Modular Perfusion System 8000 | Terumo Cardiovascular Systems Corporation | 2016-09-23 |
| 00886799000236 | Sarns™ Modular Perfusion System 8000 | Terumo Cardiovascular Systems Corporation | 2016-09-23 |
| 00886799000342 | Sarns™ Modular Perfusion System 8000 | Terumo Cardiovascular Systems Corporation | 2016-09-23 |
| 00886799001721 | Sarns™ Modular Perfusion System 8000 | Terumo Cardiovascular Systems Corporation | 2016-09-23 |
| 04987350705693 | CAPIOX | TERUMO CORPORATION | 2016-09-09 |
| 04987350705730 | CAPIOX | TERUMO CORPORATION | 2016-09-09 |
| 54987350705698 | CAPIOX | TERUMO CORPORATION | 2016-09-09 |
| 54987350705735 | CAPIOX | TERUMO CORPORATION | 2016-09-09 |
| 00886799000199 | Sarns™ Modular Perfusion System 8000 | Terumo Cardiovascular Systems Corporation | 2015-09-24 |