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FDA 510(k) Applications Submitted by Helder A Sousa
FDA 510(k) Number
Submission Date
Device Name
Applicant
K100096
01/13/2010
LINAC COLLIMATOR ASSEMBLY HOUSING (LCAH) MODEL LCAHART
INTEGRA RADIONICS, INC.
K130300
02/07/2013
HEATER-COOLER UNIT HCU 40
MAQUET CARDIOPULMONARY AG
K090506
02/25/2009
MAYFIELD INFINITY XR2 SKULL CLAMP, MODEL A-2114
INTEGRA LIFESCIENCES CORPORATION
K120868
03/22/2012
MEGA(TM) 7.5FR. 30CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MEGA(TM) 7.5FR. 40CC INTRA-AORTIC BALLOON CATHETER
DATASCOPE CORP., CARDIAC ASSIST DIVISION
K151254
05/12/2015
CARDIOSAVE Hybrid Intra-Aortic Balloon Pump
DATASCOPE CORP.
K081401
05/19/2008
MAYFIELD MR/X-RAY SKULL CLAMP
INTEGRA LIFESCIENCES CORP.
K072208
08/08/2007
MAYFIELD DISPOSABLE AND REUSABLE TITANIUM SKULL PINS
INTEGRA LIFESCIENCES CORPORATION
K112327
08/12/2011
SENSATION(TM) PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES
CARDIAC ASSIST, MAQUET CARDIOVASCULAR LLC
K112372
08/17/2011
CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP
CARDIAC ASSIST, MAQUET CARDIOVASCULAR LLC
K133598
11/22/2013
CARDIOHELP SYSTEM
MAQUET CARDIOPULMONARY AG
K172305
07/31/2017
CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon Pump
Datascope Corp.
K163542
12/16/2016
CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery Transport and Storage Case
Datascope Corp.
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