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510(k) K905464

MEDICAL PROCEDURE KITS/ARTERIAL BLOOD SAMPLING by Angiosystems, Inc. — Product Code CBT

Clearance Details

Decision
SEKD (Substantially Equivalent (kit, denovo))
Decision Date
May 31, 1991
Date Received
December 5, 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 Angiosystems, Inc.

  • K905459 — SURGICAL PROCEDURE TRAY/LAPAROSCOPY CHOLECYSTECTOM (April 5, 1991)
  • K905461 — PROCEDURE KIT/ROUTINE DENTAL PROCEDURES (March 5, 1991)
  • K905466 — STERILE DISPOSABLE SURGICAL DRAPE/ABDOMINAL DRAPE (February 11, 1991)
  • K905465 — STERILE DISPOS SURGICAL DRAPE/C-SECTION DRAPE (February 11, 1991)
  • K905460 — STERILE DISPOSABLE DRAPE/OPHTHALMIC SURGERY (February 6, 1991)
  • K905462 — PROCEDURE TRAY/FOR VARIOUS OPHTHALMIC PROCEDURES (February 6, 1991)
  • K905463 — GENERAL MEDICAL PROCEDURE KIT/SKIN PREPARATION (January 22, 1991)
  • K864688 — ARNOLD-KING PRESSURE DRESSING (January 12, 1987)
  • K843258 — ANGIO SYS BRACHIAL ANGIO DRAPE (September 21, 1984)
  • K843257 — ANGIO SYS STERILE FIELD COVER (September 21, 1984)

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)