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K Number: K860164 · Decision Jun 5, 1986

Classifications

FEI Numbers

Registration Numbers

Same Product Code

Applicant Total

136

Review Days

139

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K Number	Device Name	Decision Date	Decision
K190884	TigerPaw Pro Left Atrial Appendage Occlusion Fastener And Delivery Tool	Dec 26, 2019	Substantially Equivalent
K181122	CARDIOSAVE Intra-Aortic Balloon Pump	May 31, 2018	Substantially Equivalent
K172305	CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon Pump	Oct 12, 2017	Substantially Equivalent
K163542	CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery Transport and Storage Case	Jan 31, 2017	Substantially Equivalent
K151254	CARDIOSAVE Hybrid Intra-Aortic Balloon Pump	Jul 2, 2015	Substantially Equivalent
K133074	MEGA 8FR. 50CC AND SENSATION PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETERS AND ACCESSORIES	Dec 12, 2013	Substantially Equivalent
K071805	NETGUARD AUTOMATED CLINICIAN ALERT SYSTEM, MODEL 0998-00-1600-XX	Sep 25, 2007	Substantially Equivalent
K062569	SAFEGUARD 24 CM PRESSURE ASSISTED DRESSING	Feb 14, 2007	Substantially Equivalent
K062098	SPECTRUM MONITOR, MODEL 0998-00-1000-XXXXX	Feb 5, 2007	Substantially Equivalent
K063525	DATASCOPE FIBER OPTIC PRESSURE SENSOR INTRA-AORTIC BALLOON CATHETER AND CS300 INTRA-AORTIC BALLOON PUMP CONTROL SYSTEM	Jan 5, 2007	Substantially Equivalent

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This FDA 510(k) entry is associated with 0 registration numbers. Click on an entry to view related FDA registrations.

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Applicant

Datascope Corp.

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