510(k) K830333

ABG KITS - CMS 4000 SERIES by Currie Medical Specialties, Inc. — Product Code CBT

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: March 31, 1983
Date Received: February 1, 1983
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Arterial Blood Sampling Kit
Device Class: Class I
Regulation Number: 868.1100
Review Panel: AN
Submission Type

This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

Other clearances by Currie Medical Specialties, Inc.

K151158 — ALP VasQcare Take Home System (December 10, 2015)
K143317 — Currie Medical ALP Pediatric Calf Compression Sleeves (all sizes) (January 20, 2015)
K140092 — CURRIE MEDICAL REPROCESSED ALP CALF/THIGH/FOOT COMPRESSION SLEEVE (ALL SIZES) (April 16, 2014)
K112311 — ALP 501 RB PUMP SYSTEM (September 1, 2011)
K902441 — DISPOSABLE PROCEDURAL TRAYS #CK-XXXXX (VARIOUS) (August 23, 1990)
K874760 — CK 4900 SERIES, GOWN AND TOWEL PAK (December 10, 1987)
K872395 — CK 1600 SERIES, TOWELS (July 2, 1987)
K871737 — CK 7000 SERIES 5 IN 1 CONNECTOR AND Y-CONNECTOR (June 22, 1987)
K864816 — CK 5000 SERIES, ACE BANDAGE/ESMARK BANDAGE (January 8, 1987)
K864697 — CK 6000 SERIES, TOWELS (December 18, 1986)

Other clearances for product code CBT

K071269 — HEMODRAW ARTERIAL BLOOD SAMPLING SYSTEM (August 1, 2007)
K070340 — SECURE ARTERIAL BLOOD SAMPLING SYSTEM (March 15, 2007)
K955663 — ABC IN-LINE BLOOD SAMPLING KIT (March 17, 1997)
K954015 — ABG POINT LOK NEEDLE PROTECTION DEVICE (November 20, 1995)
K954035 — ACTI-FLEX ARTERIAL EXTENSION SET (September 25, 1995)
K950098 — NEEDLE SAFETY COVER (August 11, 1995)
K945719 — ASPIR-PULSE(TM) ARTERIAL BLOOD GAS (ABG) SYSTEM (March 16, 1995)
K944941 — PISTON SYRINGE (December 5, 1994)
K945485 — ABG NEEDLE PROTECTION (November 29, 1994)
K940575 — ASPIR-PULSE(TM) SAF-T-VENT (March 22, 1994)