510(k) K930286

DRI-VENDT/PROVENT/ACCUVENT ARTERIAL BLOOD GAS KITS by Concord/Portex — Product Code CBT

Clearance Details

Decision: SEKD (Substantially Equivalent (kit, denovo))
Decision Date: June 22, 1993
Date Received: January 21, 1993
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 Concord/Portex

K923559 — STERI-CATH MDI (October 25, 1993)
K930218 — SUBCUTANEOUS TUNNELING NEEDLE AND HANDLES (July 27, 1993)
K924541 — EPIDURAL MINIPACK (July 9, 1993)
K923127 — NEEDLE-PRO CARTRIDGE (April 29, 1993)
K923910 — HEAT MOISTURE CONDENSER (January 26, 1993)
K922749 — LOW PROFILE TRACHEOSTOMY TUBE (September 2, 1992)
K922445 — VACU-PRO (August 12, 1992)
K915452 — ANESTHESIA BREATHING CIRCUIT (February 14, 1992)
K911809 — NEW-VENT (August 26, 1991)
K912124 — TRACHEOSTOMY TUBE AND CUFF (August 16, 1991)

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)