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510(k) K924192

I.V. START KIT (AHC-50-54954 by American Healthcare Corp. — Product Code KGX

K924192 is an FDA 510(k) premarket notification submitted by American Healthcare Corp. for the device "I.V. START KIT (AHC-50-54954". The FDA issued a decision of Substantially Equivalent (kit, denovo) on August 27, 1993. The device falls under product code KGX (Tape And Bandage, Adhesive), a Class I device regulated under 21 CFR 880.5240. American Healthcare Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SEKD (Substantially Equivalent (kit, denovo))
Decision Date
August 27, 1993
Date Received
August 20, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tape And Bandage, Adhesive
Device Class
Class I
Regulation Number
880.5240
Review Panel
SU
Submission Type

Other clearances by American Healthcare Corp.

  • K043512 — EASYGLUCO IGM-0002 G2 (April 8, 2005)
  • K043543 — BLOOD GLUCOSE MONITORING SYSTEM (April 8, 2005)
  • K031501 — EASYGLUCO, MODEL IGM0002 (October 16, 2003)
  • K923941 — IRRIGATION TRAY W/ BULB SYRINGE & STERILE SALINE (June 17, 1993)
  • K923938 — IRRIGATION TRAY W/ PISTON SYRINGE & STERILE WATER (June 17, 1993)
  • K923939 — IRRIGATION TRAY W/ BULB SYRINGE & STERILE WATER (June 17, 1993)
  • K923940 — IRRIGATION TRAY W/ PISTON SYRINGE & STERILE SALINE (June 17, 1993)
  • K924193 — TRACHEOSTOMY CARE SET W/ HYDRO PEROX(AHC-20-54685) (June 16, 1993)
  • K924191 — TRACHEOSTOMY CARE SET WITH GLOVES AND EXTRA TOWEL (April 2, 1993)
  • K924194 — TRACHEOSTOMY CARE SET W/EXTRA TOWEL(AHC-20-54686) (January 6, 1993)

Other clearances for product code KGX

  • K001240 — SERAGARD INJECTION PATCH (June 21, 2000)
  • K983368 — CARE BAND ANTIBACTERIAL BANDAGES (February 17, 1999)
  • K972914 — SYVEK PATCH (December 22, 1997)
  • K943314 — ADHESIVE BANDAGES WITH OTC DRUG (January 17, 1996)
  • K952606 — TARGETT PATCH (December 21, 1995)
  • K954007 — PARALLEL (November 22, 1995)
  • K944587 — DERMIVIEW HYPOALLERGENIC CLEAR TAPE (October 30, 1995)
  • K944588 — STERILE PLASTIC DRESSING (November 7, 1994)
  • K940536 — BAND-AID(TM) BRAND ADHESIVE BANDAGE (October 3, 1994)
  • K941788 — BAND-AID BRAND ADHESIVE BANDAGES, SPORT STRIP (October 3, 1994)

FDA data resources