FDA 510(k) Applications for Medical Device Product Code "CBT"
(Arterial Blood Sampling Kit)

FDA 510(k) Number Applicant Device Name Decision Date
K801435 AKZONA, INC. ORGANON ARTERIAL BLOOD SAMPLER 07/18/1980
K870720 AMERICAN PHARMASEAL DIV. AHSC AIRLIFE ARTERIAL BLOOD GAS SAMPLING SYRINGE 03/17/1987
K843360 ANALYTICAL PRODUCTS, INC. ARTAP ARTERIAL BLOOD SAMPLING DEVICE 10/31/1984
K905464 ANGIOSYSTEMS, INC. MEDICAL PROCEDURE KITS/ARTERIAL BLOOD SAMPLING 05/31/1991
K780939 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC BARD-PARKER ARTERIAL MONITORING SYSTEM 07/17/1978
K844615 BIOTEK-CARIBBEAN BIOSAMPLER 03/21/1985
K833923 CHESEBROUGH-POND'S U.S.A. CO. MARZ-175 ARTERIAL BLOOD GAS SYRINGE 01/09/1984
K875117 CIBA CORNING DIAGNOSTICS CORP. CIBA CORNING BALANCED HEPARIN FOR CA++ 02/29/1988
K841486 CONCORD LABORATORIES, INC. ARTERIAL BLOOD SAMPLING KITS 05/23/1984
K840986 CONCORD LABORATORIES, INC. PREFILLED PULSATOR SYRINGE 04/05/1984
K833582 CONCORD LABORATORIES, INC. PULSATOR ARTERIAL BLOOD SAMPLING SYRIN 12/27/1983
K840987 CONCORD LABORATORIES, INC. VAPORIZED HEPARIN 04/05/1984
K912043 CONCORD/PORTEX ACCU-VENT(TM) WITH NEEDLE-PRO(TM) 07/05/1991
K930286 CONCORD/PORTEX DRI-VENDT/PROVENT/ACCUVENT ARTERIAL BLOOD GAS KITS 06/22/1993
K830333 CURRIE MEDICAL SPECIALTIES, INC. ABG KITS - CMS 4000 SERIES 03/31/1983
K930986 CUSTOMED, INC. BLOOD GAS KIT (NON-STERILE) REORDER NO. 0560 07/14/1993
K945485 DEVON INDUSTRIES, INC. ABG NEEDLE PROTECTION 11/29/1994
K954015 DEVON INDUSTRIES, INC. ABG POINT LOK NEEDLE PROTECTION DEVICE 11/20/1995
K821406 DHD MEDICAL PRODUCTS DIV. DIEMOLDING CORP. ARTERIAL BLOOD SAMPLING KIT 06/25/1982
K832545 DHD MEDICAL PRODUCTS DIV. DIEMOLDING CORP. ARTERIAL BLOOD SAMPLING KIT 09/26/1983
K811860 DHD MEDICAL PRODUCTS DIV. DIEMOLDING CORP. EASY-FLO ARTERIAL BLOOD GAS KIT 07/16/1981
K791465 EMDE CORP. "MOSQUITO" ARTERIAL BLOOD SAMPLER 09/17/1979
K811199 EMDE CORP. MARZ-175 05/21/1981
K771013 EMDE CORP. MOSQUITO 07/01/1977
K900302 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES UMBILICAL CORD BLOOD SAMPLING KIT 04/10/1990
K950098 HAMMER-PLANE, INC. NEEDLE SAFETY COVER 08/11/1995
K781857 JELCO LABORATORIES TRAY, ARTERIAL BLOOD GAS SAMPLING 12/11/1978
K895171 KRONNER MEDICAL BLOOD GAS SAFETY SYRINGE 11/07/1989
K872244 LAKE MEDICAL PRODUCTS, INC. CORD-ASSURE UMBILICAL BLOOD GAS KIT 07/21/1987
K801620 MARQUEST MEDICAL PRODUCTS, INC. ASPIRATOR 07/21/1980
K830312 MARQUEST MEDICAL PRODUCTS, INC. ASPIRATOR 05/25/1983
K830311 MARQUEST MEDICAL PRODUCTS, INC. AUTO STIK 05/25/1983
K820875 MARQUEST MEDICAL PRODUCTS, INC. AUTOSTIK 05/07/1982
K902632 MARQUEST MEDICAL PRODUCTS, INC. GAS-LYTE 1CC AND 3CC ARTERIAL BLOOD SAMPLERS 09/04/1990
K842008 MARQUEST MEDICAL PRODUCTS, INC. MARQUEST MICRO STIK 9000 SERIES 05/25/1984
K830310 MARQUEST MEDICAL PRODUCTS, INC. OMNISTICK 05/25/1983
K800860 MARQUEST MEDICAL PRODUCTS, INC. OMNISTIK, MQ 501GS 04/29/1980
K914778 MARTECH MEDICAL PRODUCTS, INC. NEOLINE(TM) 09/16/1992
K822786 MARTELL MEDICAL PRODUCTS, INC. MDM ARTERIAL BLOOD GAS KIT 10/21/1982
K944941 MARTELL MEDICAL PRODUCTS, INC. PISTON SYRINGE 12/05/1994
K902881 MIGADA, LTD. LAB-SITE SAFETY NEEDLE 09/26/1990
K801146 PHARMASEAL LABORATORIES SAMPLING KIT 06/04/1980
K954035 R-GROUP INTL. ACTI-FLEX ARTERIAL EXTENSION SET 09/25/1995
K831034 RADIOMETER AMERICA, INC. QUALISTICK ARTERIAL BLOOD SAMPLER 05/18/1983
K771975 RESPIRATORY CARE, INC. ARTERIAL BLOOD SAMPLING TRAY 10/28/1977
K945719 SHERWOOD MEDICAL CO. ASPIR-PULSE(TM) ARTERIAL BLOOD GAS (ABG) SYSTEM 03/16/1995
K940575 SHERWOOD MEDICAL CO. ASPIR-PULSE(TM) SAF-T-VENT 03/22/1994
K925453 SHERWOOD MEDICAL CO. SHERWOOD MEDICAL ARTERIAL BLOOD GAS KIT I 07/12/1993
K930471 SHERWOOD MEDICAL CO. SHERWOOD MEDICAL ARTERIAL BLOOD GAS KIT II 06/22/1993
K790196 SHERWOOD MEDICAL INDUSTRIES MONOJECT ARTERIAL BLOOD SAMPLING DEVICE 03/13/1979
K071269 SMITHS MEDICAL ASD, INC. HEMODRAW ARTERIAL BLOOD SAMPLING SYSTEM 08/01/2007
K070340 SMITHS MEDICAL ASD, INC. SECURE ARTERIAL BLOOD SAMPLING SYSTEM 03/15/2007
K931873 STEVEN FRANK MERCEREAU VACVENT 12/30/1993
K812338 TERUMO MEDICAL CORP. PREZA-PAK II, ARTERIAL BLOOD SAMPLING SY 09/23/1981
K897133 TRANSIDYNE GENERAL CORP. MODEL 1050 - UMBILICAL CORD BLOOD SAMPLING KIT 03/30/1990
K781616 UNITRON CORP. OMNI STIK 12/08/1978
K955663 UTAH MEDICAL PRODUCTS, INC. ABC IN-LINE BLOOD SAMPLING KIT 03/17/1997
K822248 WARNER-LAMBERT CO. DESERET ARTERIAL BLOOD SAMPLING KIT 10/21/1982


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