Datascope Corp. - FDA 510(k) Cleared Devices
Recent clearances: TigerPaw Pro Left Atrial Appendage Occlusion Fastener And Delivery Tool, CARDIOSAVE Intra-Aortic Balloon Pump, CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon Pump
136
Total
135
Cleared
0
Denied
FDA 510(k) Regulatory Record - Datascope Corp. Cardiovascular ✕
120 devices
Cleared
May 31, 2018
CARDIOSAVE Intra-Aortic Balloon Pump
Cardiovascular
31d
Cleared
Oct 12, 2017
CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon Pump
Cardiovascular
73d
Cleared
Jan 31, 2017
CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion...
Cardiovascular
46d
Cleared
Jul 02, 2015
CARDIOSAVE Hybrid Intra-Aortic Balloon Pump
Cardiovascular
51d
Cleared
Dec 12, 2013
MEGA 8FR. 50CC AND SENSATION PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETERS...
Cardiovascular
73d
Cleared
Sep 25, 2007
NETGUARD AUTOMATED CLINICIAN ALERT SYSTEM, MODEL 0998-00-1600-XX
Cardiovascular
85d
Cleared
Feb 14, 2007
SAFEGUARD 24 CM PRESSURE ASSISTED DRESSING
Cardiovascular
167d
Cleared
Feb 05, 2007
SPECTRUM MONITOR, MODEL 0998-00-1000-XXXXX
Cardiovascular
196d
Cleared
Jan 05, 2007
DATASCOPE FIBER OPTIC PRESSURE SENSOR INTRA-AORTIC BALLOON CATHETER AND CS300...
Cardiovascular
44d
Cleared
Aug 12, 2005
TRIO MONITOR
Cardiovascular
30d
Cleared
Jul 23, 2004
TRIO MONITOR
Cardiovascular
8d
Cleared
Jun 07, 2004
DATASCOPE 7.5FR. IAB CATHETER AND ACCESSORIES
Cardiovascular
25d
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