FDA 510(k) Applications Submitted by TERUMO CORP.

FDA 510(k) Number Submission Date Device Name Applicant
K031266 04/21/2003 SURSHIELD SAFETY WINGED INFUSION SET TERUMO CORP.
K100282 02/01/2010 TERUMO SURSHIELD- PUR SAFETY I.V. CATHETER TERUMO CORP.
K073474 12/11/2007 CAPIOX CIRCUIT CONNECTORS TERUMO CORP.
K040210 01/30/2004 CAPIOX RX25 HOLLOW FIBER OXYGENATOR W/WO HARDSHELL RESERVOIR TERUMO CORP.
K030449 02/11/2003 MODIFICATION TO CAPIOX SX10 HARDSHELL RESERVOIR TERUMO CORP.
K071572 06/08/2007 CAPIOX FX05 HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER TERUMO CORP.
K022115 07/01/2002 CAPIOX RX05 HOLLOW FIBER OXYGENATOR W/WITHOUT HARDSHELL RESERVOIR TERUMO CORP.
K993189 09/23/1999 CARDIOPULMONARY BYPASS PUMP TUBING - 1/4 INCH TUBING, CARDIOPULMONARY BYPASS PUMP TUBING - 3/8 INCH TUBING TERUMO CORP.
K003371 10/30/2000 PUMP TUBING WITH X-COATING TERUMO CORP.
K071494 05/30/2007 CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR AND ARTERIAL FILTER TERUMO CORP.
K040783 03/26/2004 FOUNDATION TERUMO CORP.
K980796 03/02/1998 TERUMO ALLERGY SYRINGE TERUMO CORP.
K983490 10/05/1998 TERUMO VENOJECT,LUER ADAPTER TERUMO CORP.
K090973 04/06/2009 TERUMO SURSHIELD SAFETY I.V. CATHETER (18G X 51MM & 20G X 51MM SIZES) TERUMO 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.
K092372 08/05/2009 HEARTRAIL III GUIDING CATHETER TERUMO CORP.
K033681 11/24/2003 GLIDESHEATH TERUMO CORP.
K071075 04/16/2007 TERUMO DIGITAL BLOOD PRESSURE MONITOR ES-H55A TERUMO CORP.


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