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 |
K830312 |
MARQUEST MEDICAL PRODUCTS, INC. |
ASPIRATOR |
05/25/1983 |
K801620 |
MARQUEST MEDICAL PRODUCTS, INC. |
ASPIRATOR |
07/21/1980 |
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 |