KRL · Detector, Bubble, Cardiopulmonary Bypass
Cardiovascular · 21 CFR 870.4205 · Class 2
Overview
| Product Code | KRL |
|---|---|
| Device Name | Detector, Bubble, Cardiopulmonary Bypass |
| Regulation | 21 CFR 870.4205 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| 3rd-Party Reviewable | Yes |
Identification
A cardiopulmonary bypass bubble detector is a device used to detect bubbles in the arterial return line of the cardiopulmonary bypass circuit.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (14 of 14)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K103469 | STOCKERT AIR PURGE CONTROL SYSTEM MODEL 23-45-05 | Sorin Group Deutschland GmbH | Jan 18, 2011 | SESE |
| K090698 | CAPIOX BUBBLE TRAP WITH X-COATING | Terumo Cardiovascular Systems | Jun 8, 2009 | SESE |
| K071231 | EDAC QUANTIFIER | Luna Innovations, Inc. | May 17, 2007 | SESE |
| K961364 | AUTOMATIC TUBING CLAMP SYSTEM (ATC) | Rocky Mountain Research, Inc. | Oct 31, 1996 | SESE |
| K961598 | ELS AUTOMATIC TUBING CLAMP SYSTEM | Rocky Mountain Research, Inc. | Oct 29, 1996 | SESE |
| K940651 | SARNS ULTRASONIC AIR SENSOR | 3M Health Care, Sarns | May 24, 1994 | SESE |
| K935977 | SARNS AIR DETECTION SYSTEM | 3M Health Care, Sarns | Feb 4, 1994 | SESE |
| K925661 | STOCKERT CAPS1 CARDIOPLEGIC CONTROL MODULE | Sorin Biomedica, Fiat, USA, Inc. | May 18, 1993 | SESE |
| K925541 | STOCKERT 1/4 BUBBLE SENSOR | Sorin Biomedica, Fiat, USA, Inc. | Feb 2, 1993 | SESE |
| K911632 | CAPIOX(R) BUBBLE TRAP | Terumo Medical Corp. | Jul 9, 1991 | SESE |
| K864619 | CAPS LOW LEVEL DETECTOR & DETECTOR/BUBBLE MONITOR | Shiley, Inc. | Feb 3, 1987 | SESE |
| K861860 | COBE ACCESSORY INTERFACE MODULE (AIM) | Cobe Laboratories, Inc. | Jul 18, 1986 | SESE |
| K842054 | COBE AEPS | Cobe Laboratories, Inc. | Aug 2, 1984 | SESE |
| K803102 | ARTERIAL BUBBLE TRAP K-20 | Delta Medical Industries | Dec 22, 1980 | SESE |
Top Applicants
- Sorin Biomedica, Fiat, USA, Inc. — 2 clearances
- Rocky Mountain Research, Inc. — 2 clearances
- Cobe Laboratories, Inc. — 2 clearances
- 3M Health Care, Sarns — 2 clearances
- Terumo Medical Corp. — 1 clearance
