FDA 510(k) Applications Submitted by TERUMO MEDICAL CORP.

FDA 510(k) Number Submission Date Device Name Applicant
K082644 09/11/2008 GLIDESHEATH TERUMO MEDICAL CORP.
K953940 08/21/1995 TERUMO RETRACTABLE NEEDLE (RN) SYRINGE TERUMO MEDICAL CORP.
K010103 01/12/2001 SURSHIELD WINGED INFUSION SET TERUMO MEDICAL CORP.
K040531 03/01/2004 TERUMO SURGUARD2 SAFETY NEEDLE TERUMO MEDICAL CORP.
K031453 05/07/2003 TERUMO SURGUARD 2 SAFETY NEEDLE TERUMO MEDICAL CORP.
K051865 07/11/2005 TERUMO SURGUARD 2 SAFETY NEEDLE OR SIMILAR TERUMO MEDICAL CORP.
K052034 07/28/2005 TERUMO SYRINGE WITH/WITHOUT NEEDLE TERUMO MEDICAL CORP.
K012646 08/13/2001 TERUMO 30 GAUGE HYPODERMIC NEEDLE TERUMO MEDICAL CORP.
K013164 09/21/2001 SURSHIELD SAFETY WINGED BLOOD COLLECTION SET TERUMO MEDICAL CORP.
K003571 11/20/2000 SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE TERUMO MEDICAL CORP.
K024249 12/23/2002 TERUMO SURGUARD SAFETY SYRINGE TERUMO MEDICAL CORP.
K111606 06/09/2011 PINNACLE PRECISION ACCESS SYSTEM TERUMO MEDICAL CORP.
K102008 07/16/2010 GLIDESHEATH TERUMO MEDICAL CORP.
K071630 06/14/2007 TERUMO 31G THINPRO INSULIN SYRINGE TERUMO MEDICAL CORP.
K082362 08/18/2008 SURSHIELD SAFETY I.V. CATHETER TERUMO MEDICAL CORP.
K082997 10/08/2008 TERUMO HYBRIA CLOSED SYSTEM SAFETY I.V. CATHETER TERUMO MEDICAL CORP.
K991973 06/11/1999 CAPIOX SX10 HARDSHELL RESEVOIR TERUMO MEDICAL CORP.
K002026 07/03/2000 CAPIOX ARTERIAL FILTER TERUMO MEDICAL CORP.
K993772 11/08/1999 X-COATED CAPIOX SX18 AND SX25 HOLLOW FIBER OXYGENATOR WITH/ WITHOUT DETACHABLE HARDSHELL RESERVOIR TERUMO MEDICAL CORP.
K970708 02/26/1997 CLIRANS T-SERIES HOLLOW FIBER DIALYZERS TERUMO MEDICAL CORP.
K961445 04/16/1996 RADIFOCUS GLIDEWIRE FOR CORONARY USE WITH PLATINUM (OR GOLD) COIL TERUMO MEDICAL CORP.
K955801 12/22/1995 RADIFOCUS GLIDEWIRE GT WITH GOLD COIL,GLIDEWIRE GOLD TERUMO MEDICAL CORP.
K980181 01/20/1998 TERUMO DISPOSABLE HYPODERMC SYRINGE TERUMO MEDICAL CORP.
K991406 04/22/1999 TERUMO SURFLO FLEX I.V. CATHETER AND TERUMO SURFLASH I.V. CATHETER TERUMO MEDICAL CORP.
K971937 05/27/1997 CLIMBER - PARTIALLY COATED GUIDE WIRE FOR ENDOSCOPIC USE TERUMO MEDICAL CORP.
K992802 08/19/1999 TERUMO U-100 INSULIN SYRINGE TERUMO MEDICAL CORP.
K090040 01/06/2009 RADIFOCUS GLIDECATH (OR RADIFOCUS GLIDECATH XP) TERUMO MEDICAL CORP.
K070423 02/13/2007 TR BAND TERUMO MEDICAL CORP.
K080415 02/14/2008 DEVICE MODIFICATION TO PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH TERUMO MEDICAL CORP.
K110540 02/25/2011 TERUMO SUPPORT CATHETER TERUMO MEDICAL CORP.
K080563 02/28/2008 RUNTHROUGH NS EXTENSION WIRE TERUMO MEDICAL CORP.
K060666 03/14/2006 CAROTID ACCESS KIT TERUMO MEDICAL CORP.
K081045 04/14/2008 DESTINATION RENAL GUIDING SHEATH TERUMO MEDICAL CORP.
K081046 04/14/2008 PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH TERUMO MEDICAL CORP.
K091329 05/05/2009 PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH TERUMO MEDICAL CORP.
K111556 06/06/2011 GLIDECROSS SUPPORT CATHETER TERUMO MEDICAL CORP.
K051601 06/16/2005 PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH TERUMO MEDICAL CORP.
K052185 08/11/2005 DESTINATION CAROTID GUIDING SHEATH TERUMO MEDICAL CORP.
K062446 08/22/2006 MODIFICATION TO PINNACLE ROII HIFLOW INTRODUCER SHEATH TERUMO MEDICAL CORP.
K082519 09/02/2008 FINECROSS MG CORONARY MICRO-GUIDE CATHETER TERUMO MEDICAL CORP.
K082736 09/18/2008 RADIFOCUS OPTITORQUE ANGIOGRAPHIC CATHETER TERUMO MEDICAL CORP.
K062858 09/25/2006 MODIFICATION TO GLIDESHEATH TERUMO MEDICAL CORP.
K082847 09/29/2008 PINNACLE ROII INTRODUCER SHEATH TERUMO MEDICAL CORP.
K063372 11/08/2006 RADIFOCUS GLIDEWIRE ADVANTAGE TERUMO MEDICAL CORP.
K033583 11/13/2003 PROGREAT TERUMO MEDICAL CORP.
K063695 12/13/2006 RUNTHROUGH NS TERUMO MEDICAL CORP.
K033913 12/17/2003 PROGREAT TERUMO MEDICAL CORP.
K960074 01/11/1996 CAPIOX SX10 HOLLOW FIBER OXYGENATOR WITH DETACHABLE HARDSHELL VENOUS RESERVOIR TERUMO MEDICAL CORP.
K970463 02/06/1997 CAPIOX E HOLLOW FIBER OXYGENATOR WITH INTEGRATED HEAT EXCHANGER/ARTERIAL RESERVOIR TERUMO MEDICAL CORP.
K961000 03/12/1996 CAPIOX SX18 HOLLOW FIBER OXYGENATOR WITH AND WITHOUT DETACHABLE HARDSHELL RESERVOIR TERUMO MEDICAL CORP.
K980935 03/12/1998 CAPIOX SX HARDSHELL RESERVOIR TERUMO MEDICAL CORP.
K961734 05/03/1996 CAPIOX 308 HOLLOW FIBER OXYGENATOR W/INTEGRATED HEAT EXCHANGE TERUMO MEDICAL CORP.
K001474 05/11/2000 TERUMO U-100 INSULIN SYRING TERUMO MEDICAL CORP.
K982223 06/24/1998 CAPIOX SX HARDSHELL RESEVOIR TERUMO MEDICAL CORP.
K982467 07/15/1998 CAPIOX CARDIOPLEGIA TERUMO MEDICAL CORP.
K962981 08/01/1996 CAPIOX SP PUMP HEAD TERUMO MEDICAL CORP.
K973516 09/17/1997 CAPIOX HEMOCONCENTRATOR TERUMO MEDICAL CORP.
K013550 10/24/2001 CLIRANS E-SERIES DIALYZER TERUMO MEDICAL CORP.
K063613 12/05/2006 MODIFICATION TO TERUMO SYRINGE WITH/WITHOUT NEEDLE TERUMO MEDICAL CORP.
K962667 07/09/1996 CAPIOX SX25 HOLLOW FIBER OXYGENATOR WITH DETACHABLE HARDSHELL RESERVOIR TERUMO MEDICAL CORP.
K023271 10/01/2002 TERUMO SYRINGE WITH/WITHOUT NEEDLE TERUMO MEDICAL CORP.
K000387 02/07/2000 TERUMO NEEDLE WITH LOCKING SHEATH TERUMO MEDICAL CORP.
K981359 04/14/1998 GT LEGGIERO TERUMO MEDICAL CORP.
K992051 06/18/1999 RADIFOCUS OPTITORQUE TERUMO MEDICAL CORP.
K012812 08/22/2001 CAROTID GUIDING SHEATH TERUMO MEDICAL CORP.
K012854 08/24/2001 RENAL GUIDING SHEATH TERUMO MEDICAL CORP.
K003425 11/03/2000 CLIRANS E-SERIES HOLLOW FIBER DIALYZERS TERUMO MEDICAL CORP.
K003424 11/03/2000 PINNACLE R/O II OR RADIFOCUS INTRODUCER II TERUMO MEDICAL CORP.
K984260 11/25/1998 PINNACLE R/O OR REDIFOCUS INTRODUCER R/O (COMPRISED OF A SHEATH & DILATOR) TERUMO MEDICAL CORP.


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