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Panels › Cardiovascular › Product code KRB · Class 2

Probe, Thermodilution

Regulation 870.1915

0510(k)s in 12 months (37 all time)

0recalls in 12 months (4 all time)

4recalls that name a 510(k)

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Top companies in KRB

Company	510(k)s	Recalls
Gould, Inc.	4	0
ICU Medical, Inc.	0	3
Instrumentation Laboratory CO	3	0
Pulsion Medical Systems AG	3	0
American Edwards Laboratories	2	0
Andover Medical, Inc.	2	0
Edwards Laboratories	2	0
Abbott Laboratories	1	0
Ackrad Laboratories	1	0
American Pharmaseal Div. Ahsc	1	0

Date	Firm and product	Code	Linked 510(k)
Oct 5, 2018	ICU Medical, Inc. Iced Thermoset Closed-Loop Injectate Delivery System for cold Injectate. 1 unit per Cavity #2-4"x9" Cav/20 pieces per case R1-15645 Terminated	KRB	K884318
Oct 5, 2018	ICU Medical, Inc. Iced Thermoset Closed-Loop Injectate Delivery System for cold Injectate. 1 unit per Cavity #6x12x2.6 Cav/10 pieces per case R1-6090 Terminated	KRB	K884318
Oct 5, 2018	ICU Medical, Inc. Thermoset Room Temperature Closed Loop Injectate Delivery System. 1 unit per Cavity #3 Cavity Deep/20 pieces per case R1-6090 Terminated	KRB	K884318
Feb 17, 2015	Pulsion Medical Inc Pulsiocath PiCCO ProAQT Monitoring Kit, single-use cardiac output (CO) sensor, one unit per plastic sterilizable package. Product Usage: Measures cardiac output by the thermodilution method, measure Terminated	KRB	K991886

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