Datascope Corp., Cardiac Assist Division - FDA 510(k) Cleared Devices
Recent clearances: AIR-BAND RADIAL COMPRESSION DEVICE, SENSATION PLUS 7.5FR. 40CC INTRA-AORTIC BALLOON (IAB) CATHETER AND ACCESSORIES, MEGA(TM) 7.5FR. 30CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MEGA(TM) 7.5FR. 40CC INTRA-AORTIC BALLOON CATHETER
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Datascope Corp., Cardiac Assist Division Cardiovascular ✕
4 devices
Cleared
Nov 09, 2012
AIR-BAND RADIAL COMPRESSION DEVICE
Cardiovascular
94d
Cleared
Sep 06, 2012
SENSATION PLUS 7.5FR. 40CC INTRA-AORTIC BALLOON (IAB) CATHETER AND ACCESSORIES
Cardiovascular
9d
Cleared
Apr 20, 2012
MEGA(TM) 7.5FR. 30CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MEGA(TM)...
Cardiovascular
29d
Cleared
Jun 18, 2009
DATASCOPE'S 8FR. 50CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MODELS...
Cardiovascular
31d