Medical Device Manufacturer · US , Elkton , MD

Terumo Cardiovascular Systems Corp. - FDA 510(k) Cleared Devices

43 submissions · 43 cleared · Since 2000

43

Total

43

Cleared

0

Denied

FDA 510(k) Regulatory Record - Terumo Cardiovascular Systems Corp. Cardiovascular ✕

38 devices

1-12 of 38

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

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