FDA 510(k) Applications Submitted by MARK UNTERREINER

FDA 510(k) Number Submission Date Device Name Applicant
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.
K091417 05/13/2009 SINGLE USE GUIDEWIRE, MODELS G-240-2527S, G-240-2545S, G-240-2527A, G-240-2545A, G-240-3527S, G-240-3545S & G-240-3527A TERUMO CORP.
K111556 06/06/2011 GLIDECROSS SUPPORT CATHETER TERUMO MEDICAL CORP.
K051601 06/16/2005 PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH TERUMO MEDICAL CORP.
K092372 08/05/2009 HEARTRAIL III GUIDING CATHETER TERUMO 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.
K113335 11/14/2011 HEARTRAIL III GUIDING CATHETER TERUMO Corporation
K033681 11/24/2003 GLIDESHEATH TERUMO CORP.
K063695 12/13/2006 RUNTHROUGH NS TERUMO MEDICAL CORP.
K033913 12/17/2003 PROGREAT TERUMO MEDICAL CORP.


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