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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)

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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

Decided	510(k)	Device and applicant	Code
Jan 18, 2011	K103469	STOCKERT AIR PURGE CONTROL SYSTEM MODEL 23-45-05 Sorin Group Deutschland GmbH	KRL
Jun 8, 2009	K090698	CAPIOX BUBBLE TRAP WITH X-COATING Terumo Cardiovascular Systems	KRL
May 17, 2007	K071231	EDAC QUANTIFIER Luna Innovations, Inc.	KRL
Oct 31, 1996	K961364	AUTOMATIC TUBING CLAMP SYSTEM (ATC) Rocky Mountain Research, Inc.	KRL
Oct 29, 1996	K961598	ELS AUTOMATIC TUBING CLAMP SYSTEM Rocky Mountain Research, Inc.	KRL
May 24, 1994	K940651	SARNS ULTRASONIC AIR SENSOR 3M Health Care, Sarns	KRL
Feb 4, 1994	K935977	SARNS AIR DETECTION SYSTEM 3M Health Care, Sarns	KRL
May 18, 1993	K925661	STOCKERT CAPS1 CARDIOPLEGIC CONTROL MODULE Sorin Biomedica, Fiat, USA, Inc.	KRL
Feb 2, 1993	K925541	STOCKERT 1/4 BUBBLE SENSOR Sorin Biomedica, Fiat, USA, Inc.	KRL
Jul 9, 1991	K911632	CAPIOX(R) BUBBLE TRAP Terumo Medical Corp.	KRL
Feb 3, 1987	K864619	CAPS LOW LEVEL DETECTOR & DETECTOR/BUBBLE MONITOR Shiley, Inc.	KRL
Jul 18, 1986	K861860	COBE ACCESSORY INTERFACE MODULE (AIM) Cobe Laboratories, Inc.	KRL
Aug 2, 1984	K842054	COBE AEPS Cobe Laboratories, Inc.	KRL
Dec 22, 1980	K803102	ARTERIAL BUBBLE TRAP K-20 Delta Medical Industries	KRL

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