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510(k) K902632

GAS-LYTE 1CC AND 3CC ARTERIAL BLOOD SAMPLERS by Marquest Medical Products, Inc. — Product Code CBT

K902632 is an FDA 510(k) premarket notification submitted by Marquest Medical Products, Inc. for the device "GAS-LYTE 1CC AND 3CC ARTERIAL BLOOD SAMPLERS". The FDA issued a decision of Substantially Equivalent on September 4, 1990. The device falls under product code CBT (Arterial Blood Sampling Kit), a Class I device regulated under 21 CFR 868.1100. Marquest Medical Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 4, 1990
Date Received
June 14, 1990
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 Marquest Medical Products, Inc.

  • K050066 — C-CO2 COLORIMETRIC CO2 INDICATOR (March 1, 2005)
  • K970478 — SCT 3000 HEATED HUMIDIFIER (July 16, 1997)
  • K962223 — WATER CHAMBERS FOR ST 3000 HEATED HUMIDIFIER (January 14, 1997)
  • K962220 — HEATED WIRE CIRCUITS FOR SCT 3000 HEATED HUMIDIFIER (January 14, 1997)
  • K960972 — DISPOSABLE GAS SAMPLING INTERFACE KITS (October 18, 1996)
  • K961838 — RESPIRGARD II, SPIROGARD (October 18, 1996)
  • K904690 — TEMP MARQ(TM) CONVECTIVE WARMING SYSTEM (February 1, 1991)
  • K903138 — MARQUEST SCT 3000, HEATED HUMIDIFICATION SYSTEM (October 11, 1990)
  • K903307 — TEMP MARQ TEMPERATURE TREND INDICATOR (August 17, 1990)
  • K880979 — MARQUEST SCT 2000, HEATED HUMIDIFICATION SYSTEM (July 15, 1988)

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)

FDA data resources