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
43 devices
26-43 of 43
Cleared Sep 15, 2005
CAPIOX RX15 HOLLOW, FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIR
K051997 · DTZ
Cardiovascular · 52d
Cleared Sep 12, 2005
CAPIOX AF125X ARTERIAL FILTER
K052205 · DTM
Cardiovascular · 31d
Cleared Mar 01, 2004
CAPIOX FLEXIBLE VENOUS RESERVOIR
K040023 · DTN
Cardiovascular · 54d
Cleared Aug 01, 2003
TERUMO AL8X ARTERIAL FILTER WITH X-COATING
K032128 · DTM
Cardiovascular · 22d
Cleared Jul 29, 2003
VIRTUOSAPH
K031891 · GCJ
General & Plastic Surgery · 46d
Cleared May 14, 2003
CAPIOX CARDIOTOMY RESERVOIR
K030505 · DPW
Cardiovascular · 84d
Cleared Mar 20, 2003
ADVANCED PERFUSION SYSTEM 1 (100/120 VOLT),ADVANCED PERFUSION SYSTEM 1...
K022947 · DTQ
Cardiovascular · 196d
Cleared Nov 26, 2002
CIRCUIT TUBINGS WITH X-COATING
K023056 · DWF
Cardiovascular · 74d
Cleared Jun 20, 2002
TERUMO KHURI MYOCARDIAL PH MONITORING SYSTEM
K020967 · CBZ
Anesthesiology · 87d
Cleared Jun 10, 2002
TERUMO GAS FILTER
K021020 · CAH
General Hospital · 73d
Cleared Apr 04, 2002
SARNS CENTRIFUGAL PUMP WITH XCOATING, MODEL 164275X
K020998 · KFM
Cardiovascular · 7d
Cleared Jan 22, 2002
PUMP TUBING
K013578 · DWE
Cardiovascular · 85d
Cleared Dec 11, 2001
CAPIOX SX10 HOLLOW FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIR WITH...
K010443 · DTZ
Cardiovascular · 300d
Cleared Nov 15, 2001
CAPIOX RX HARDSHELL RESERVOIR
K013526 · DTN
Cardiovascular · 23d
Cleared Aug 15, 2001
CAPIOX SP PUMP WITH X-COATING PRODUCT CODE: CXSP45X
K012209 · KFM
Cardiovascular · 30d
Cleared Jul 09, 2001
CAPIOX ARTERIAL FILTER WITH X-COATING, PRODUCT CODE CX*AFO2X
K011804 · DTM
Cardiovascular · 28d
Cleared Feb 07, 2001
ADAPTERS WITH X-COATING
K003604 · DTL
Cardiovascular · 78d
Cleared Aug 22, 2000
CAPIOX SX HARDSHELL RESERVOIR WITH X-COATING
K002238 · DTN
Cardiovascular · 29d
Filters