Terumo Cardiovascular Systems Corp.

FDA 510(k) & PMA Approved Devices — 38 products

Total Devices38

Categories0

Latest FDA decision

Type	Number	Device Name	Code	Date	Actions
510(k)	K130359	CAPIOX SX18 HOLLOW FIBER OXYGENATOR WITH DETACHABLE HARDSHELL RESERVOIR, CAPIOX SX25 HOLLOW FIBER OXGENATOR WITH DETACHA	DTZ	2013-03-13	View
510(k)	K130333	CAPIX RX HOLLOW FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIR	DTZ	2013-03-13	View
510(k)	K123039	CDI BLOOD PARAMETER MONITORING SYSTEM 500	DRY	2012-11-20	View
510(k)	K113214	TLINK DATA MANAGEMENT SYSTEM (DMS)	DXJ	2012-02-07	View
510(k)	K112587	ADVANCED PERFUSION SYSTEM 1 (APS1) TUBE CLAMP ASSEMBLY, ROLLER PUMP 6 INCH CLASSIC COLOR,	DWB	2011-12-19	View
510(k)	K092789	VIRTUOSAPH PLUS ENDOSCOPIC VESSEL HARVESTING SYSTEM	GCJ	2010-05-12	View
510(k)	K092644	TERUMO PRESSURE ISOLATOR	DRS	2009-12-10	View
510(k)	K083747	TERUMO PALL AL3X ARTERIAL FILTER	DTM	2009-08-20	View
510(k)	K083834	TERUMO PALL AL6X ARTERIAL FILTER	DTM	2009-04-17	View
510(k)	K090878	MODIFICATION TO TERUMO'S TENDERFLOW PEDIATRIC VENOUS RETURN CANNULAE (X-COATING)	DWF	2009-04-03	View
510(k)	K082321	TERUMO ROCSAFE HYBRID PERFUSION SYSTEM	KFM	2009-02-13	View
510(k)	K083194	VIRTUOSAPH (TM) ENDOSCOPIC VEIN HARVESTING DISPOSABLE SYSTEM, MODEL MCVS550	GCJ	2009-01-16	View
510(k)	K083301	X-COATED TERUMO AND SARNS DUAL STAGE VENOUS RETURN CATHETERS, SARNS MALLEABLE VENOUS AND DUAL STAGE RETURN CATHETERS	DWF	2008-12-18	View
510(k)	K080034	THREE STAGE VENOUS RETURN CANNULA, MODEL 816460	DWF	2008-06-17	View
510(k)	K080774	CAPIOX SP PUMP (WITH OR WITHOUT X-COATING)	KFM	2008-04-17	View
510(k)	K071521	TERUMO HX2 TEMPERATURE MANAGEMENT SYSTEM	DWC	2007-11-21	View
510(k)	K070839	MODIFICATION TO CAPIOX FLEXIBLE VENOUS RESERVOIR	DTN	2007-04-24	View
510(k)	K063618	TENDERFLOW PERIATRIC ARTERIAL CANNULA	DWF	2007-03-13	View
510(k)	K062597	TENDERFLOW PEDIATRIC VENOUS RETURN CANNULA	DWF	2006-11-03	View
510(k)	K062381	CAPIOX RX OXYGENATOR WITH OR WITHOUT RESERVOIR	DTZ	2006-08-24	View