CBT · Arterial Blood Sampling Kit
Anesthesiology · 21 CFR 868.1100 · Class 1
Overview
| Product Code | CBT |
|---|---|
| Device Name | Arterial Blood Sampling Kit |
| Regulation | 21 CFR 868.1100 |
| Device Class | Class 1 |
| Review Panel | Anesthesiology |
Identification
An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood gas determinations. The kit may include a syringe, needle, cork, and heparin.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.
Recent Cleared Devices (20 of 58)
Showing 20 most recent of 58 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K071269 | HEMODRAW ARTERIAL BLOOD SAMPLING SYSTEM | Smiths Medical Asd, Inc. | Aug 1, 2007 | SESE |
| K070340 | SECURE ARTERIAL BLOOD SAMPLING SYSTEM | Smiths Medical Asd, Inc. | Mar 15, 2007 | SESE |
| K955663 | ABC IN-LINE BLOOD SAMPLING KIT | Utah Medical Products, Inc. | Mar 17, 1997 | SESE |
| K954015 | ABG POINT LOK NEEDLE PROTECTION DEVICE | Devon Industries, Inc. | Nov 20, 1995 | SESE |
| K954035 | ACTI-FLEX ARTERIAL EXTENSION SET | R-Group Intl. | Sep 25, 1995 | SESE |
| K950098 | NEEDLE SAFETY COVER | Hammer-Plane, Inc. | Aug 11, 1995 | SESE |
| K945719 | ASPIR-PULSE(TM) ARTERIAL BLOOD GAS (ABG) SYSTEM | Sherwood Medical Co. | Mar 16, 1995 | SESK |
| K944941 | PISTON SYRINGE | Martell Medical Products, Inc. | Dec 5, 1994 | SESE |
| K945485 | ABG NEEDLE PROTECTION | Devon Industries, Inc. | Nov 29, 1994 | SESE |
| K940575 | ASPIR-PULSE(TM) SAF-T-VENT | Sherwood Medical Co. | Mar 22, 1994 | SESE |
| K931873 | VACVENT | Steven Frank Mercereau | Dec 30, 1993 | SEKD |
| K930986 | BLOOD GAS KIT (NON-STERILE) REORDER NO. 0560 | Customed, Inc. | Jul 14, 1993 | SEKD |
| K925453 | SHERWOOD MEDICAL ARTERIAL BLOOD GAS KIT I | Sherwood Medical Co. | Jul 12, 1993 | SEKD |
| K930471 | SHERWOOD MEDICAL ARTERIAL BLOOD GAS KIT II | Sherwood Medical Co. | Jun 22, 1993 | SEKD |
| K930286 | DRI-VENDT/PROVENT/ACCUVENT ARTERIAL BLOOD GAS KITS | Concord/Portex | Jun 22, 1993 | SEKD |
| K914778 | NEOLINE(TM) | Martech Medical Products, Inc. | Sep 16, 1992 | SESK |
| K912043 | ACCU-VENT(TM) WITH NEEDLE-PRO(TM) | Concord/Portex | Jul 5, 1991 | SEKD |
| K905464 | MEDICAL PROCEDURE KITS/ARTERIAL BLOOD SAMPLING | Angiosystems, Inc. | May 31, 1991 | SEKD |
| K902881 | LAB-SITE SAFETY NEEDLE | Migada, Ltd. | Sep 26, 1990 | SESE |
| K902632 | GAS-LYTE 1CC AND 3CC ARTERIAL BLOOD SAMPLERS | Marquest Medical Products, Inc. | Sep 4, 1990 | SESE |
Top Applicants
- Marquest Medical Products, Inc. — 8 clearances
- Sherwood Medical Co. — 4 clearances
- Concord Laboratories, Inc. — 4 clearances
- Emde Corp. — 3 clearances
- Dhd Medical Products Div. Diemolding Corp. — 3 clearances
