Terumo Cardiovascular Systems Corp. - FDA 510(k) Cleared Devices
Recent clearances: Terumo Capiox SX18 Oxygenator/ Hardshell Reservoir, Terumo Capiox SX18 Oxygenator/ Hardshell Reservoir with Xcoating, Terumo Capiox SX25 Oxygenator/Hardshell Reservoir, Terumo Capiox SX25 Oxygenator/Hardshell Reservoir with Xcoating, CDI BLOOD PARAMETER MONITORING SYSTEM 500, ADVANCED PERFUSION SYSTEM 1
43
Total
43
Cleared
0
Denied
FDA 510(k) Regulatory Record - Terumo Cardiovascular Systems Corp. Cardiovascular ✕
38 devices
Cleared
Dec 02, 2015
Terumo Capiox SX18 Oxygenator/ Hardshell Reservoir, Terumo Capiox SX18...
Cardiovascular
33d
Cleared
Jul 25, 2014
CDI BLOOD PARAMETER MONITORING SYSTEM 500
Cardiovascular
240d
Cleared
Feb 20, 2014
ADVANCED PERFUSION SYSTEM 1
Cardiovascular
311d
Cleared
Feb 18, 2014
SARNS SOFT-FLOW AORTIC CANNULA
Cardiovascular
196d
Cleared
Feb 03, 2014
SARNS HIGH FLOW AORTIC ARCH CANNULA
Cardiovascular
109d
Cleared
Mar 13, 2013
CAPIX RX HOLLOW FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIR
Cardiovascular
30d
Cleared
Mar 13, 2013
CAPIOX SX18 HOLLOW FIBER OXYGENATOR WITH DETACHABLE HARDSHELL RESERVOIR,...
Cardiovascular
28d
Cleared
Nov 20, 2012
CDI BLOOD PARAMETER MONITORING SYSTEM 500
Cardiovascular
53d
Cleared
Feb 07, 2012
TLINK DATA MANAGEMENT SYSTEM (DMS)
Cardiovascular
99d
Cleared
Dec 19, 2011
ADVANCED PERFUSION SYSTEM 1 (APS1) TUBE CLAMP ASSEMBLY, ROLLER PUMP 6 INCH...
Cardiovascular
104d
Cleared
Dec 10, 2009
TERUMO PRESSURE ISOLATOR
Cardiovascular
105d
Cleared
Aug 20, 2009
TERUMO PALL AL3X ARTERIAL FILTER
Cardiovascular
246d
Looking for a specific device from Terumo Cardiovascular...? Search by device name or K-number.
Search all Terumo Cardiovascular... devices