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.