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 |
| 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 |
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