Terumo Medical Corp. - FDA 510(k) Cleared Devices

Cleared Nov 14, 2001

CAROTID GUIDING SHEATH

K012812 · DYB

Cardiovascular · 84d

Cleared Nov 21, 2000

PINNACLE R/O II OR RADIFOCUS INTRODUCER II

K003424 · DYB

Cardiovascular · 18d

Cleared Sep 06, 2000

CAPIOX ARTERIAL FILTER

K002026 · DTM

Cardiovascular · 65d

Cleared Jun 05, 2000

X-COATED CAPIOX SX18 AND SX25 HOLLOW FIBER OXYGENATOR WITH/ WITHOUT...

K993772 · DTZ

Cardiovascular · 210d

Cleared Sep 03, 1999

CAPIOX SX10 HARDSHELL RESEVOIR

K991973 · DTN

Cardiovascular · 84d

Cleared Aug 10, 1999

RADIFOCUS OPTITORQUE

K992051 · DQO

Cardiovascular · 53d

Cleared Jun 23, 1999

CAPIOX CARDIOPLEGIA

K982467 · DTR

Cardiovascular · 343d

Cleared Jan 27, 1999

GT LEGGIERO

K981359 · DQY

Cardiovascular · 288d

Cleared Jan 26, 1999

PINNACLE R/O OR REDIFOCUS INTRODUCER R/O (COMPRISED OF A SHEATH & DILATOR)

K984260 · DYB

Cardiovascular · 62d

Cleared Sep 10, 1998

CAPIOX SX HARDSHELL RESEVOIR

K982223 · DTN

Cardiovascular · 78d

Cleared May 14, 1998

CAPIOX SX HARDSHELL RESERVOIR

K980935 · DTN

Cardiovascular · 63d

Cleared Jul 07, 1997

CAPIOX 308 HOLLOW FIBER OXYGENATOR W/INTEGRATED HEAT EXCHANGE

K961734 · DTZ

Cardiovascular · 430d

Cleared May 06, 1997

CAPIOX E HOLLOW FIBER OXYGENATOR WITH INTEGRATED HEAT EXCHANGER/ARTERIAL...

K970463 · DTZ

Cardiovascular · 89d

Cleared Feb 25, 1997

CAPIOX SP PUMP HEAD

K962981 · KFM

Cardiovascular · 208d

Cleared Oct 16, 1996

CAPIOX SX10 HOLLOW FIBER OXYGENATOR WITH DETACHABLE HARDSHELL VENOUS RESERVOIR

K960074 · DTZ

Cardiovascular · 279d

Cleared Oct 07, 1996

CAPIOX SX25 HOLLOW FIBER OXYGENATOR WITH DETACHABLE HARDSHELL RESERVOIR

K962667 · DTZ

Cardiovascular · 90d

Cleared Oct 02, 1996

CAPIOX SX18 HOLLOW FIBER OXYGENATOR WITH AND WITHOUT DETACHABLE HARDSHELL...

K961000 · DTZ

Cardiovascular · 204d

Cleared Jul 09, 1996

RADIFOCUS GLIDEWIRE FOR CORONARY USE WITH PLATINUM (OR GOLD) COIL

K961445 · DQX

Cardiovascular · 84d

Cleared Feb 02, 1996

RADIFOCUS GLIDEWIRE GT WITH GOLD COIL,GLIDEWIRE GOLD

K955801 · DQX

Cardiovascular · 42d

Cleared Nov 27, 1995

RADIFOCUS INTRODUCER II KIT

K954234 · DYB

Cardiovascular · 77d

Cleared Oct 18, 1995

RADIFOCUS GLIDEWIRE FOR CORONARY USE WITH PLATINUM (OR GOLD) COIL

K953533 · DQX

Cardiovascular · 83d

Cleared Jul 25, 1995

CAPIOX ARTERIAL FILTER

K943917 · DTM

Cardiovascular · 348d

Cleared Sep 02, 1993

CAPIOX SX HOLLOW FIBER OXYGENATOR

K922799 · DTZ

Cardiovascular · 449d

Cleared Jun 10, 1993

TERUMO CORONARY GUIDE WIRE

K925852 · DQX

Cardiovascular · 205d

Cleared Nov 23, 1992

RADIFOCUS(R) (CATHETER) GUIDE WIRE

K924202 · DQX

Cardiovascular · 95d