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510(k) K843360

ARTAP ARTERIAL BLOOD SAMPLING DEVICE by Analytical Products, Inc. — Product Code CBT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 1984
Date Received
August 28, 1984
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 Analytical Products, Inc.

  • K924814 — API 20E/UNISCEPT 20E (March 11, 1993)
  • K923684 — API UNISCEPT MIC/TYPE 2 AND 3 AND MICRO MIC (December 3, 1992)
  • K922926 — API UNISCEPT KB/TYPE 2 AND 3 (October 13, 1992)
  • K901559 — MODIFICATION TO API UNISCEPT 20GP (September 10, 1990)
  • K901390 — DMAC INDOLE REAGENT (April 16, 1990)
  • K895796 — API UNISCEPT KB (November 13, 1989)
  • K884510 — MODIFICATION MICRO-MIC (November 22, 1988)
  • K884509 — MODIFICATION MIC/API UNISCEPT(R) (November 22, 1988)
  • K880598 — MODIFICATIONS TO API UNISCEPT (R) KB (March 23, 1988)
  • K874466 — API UNISCEPT(R) MICRO-MIC(R) SYSTEM/UNISCEPT MIC (December 9, 1987)

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)