FDA 510(k) Applications Submitted by SANDI HARTKA, M.A.S., R.A.C.

FDA 510(k) Number Submission Date Device Name Applicant
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.
K041358 05/21/2004 VENOJECT LUER ADAPTER TERUMO EUROPE N.V.
K121607 06/01/2012 TERUMO(R) NEEDLE TERUMO (PHILIPPINES) CORPORATION
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.
K122544 08/21/2012 TERUMO SURFLASH SAFETY I.V. CATHETER TERUMO Corporation
K973516 09/17/1997 CAPIOX HEMOCONCENTRATOR TERUMO MEDICAL CORP.
K123267 10/19/2012 SURFFLASH(R) PLUS SAFETY I.V. CATHETER KOFU FACTORY OF TERUMO CORP.
K013550 10/24/2001 CLIRANS E-SERIES DIALYZER TERUMO MEDICAL CORP.
K113422 11/21/2011 TERUMO SURGUARD 3 SAFETY NEEDLE TERUMO SURGUARD 3 HYPODERMIC SYRINGE WITH SAFETY NEEDLE TERUMO (PHILIPPINES) CORPORATION
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.


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