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510(k) K043126

ASSIST HEADER CLEANER by Alcavis International, Inc. — Product Code LIF

K043126 is an FDA 510(k) premarket notification submitted by Alcavis International, Inc. for the device "ASSIST HEADER CLEANER". The FDA issued a decision of Substantially Equivalent on February 3, 2005. The device falls under product code LIF (Dialyzer Reprocessing System), a Class II device regulated under 21 CFR 876.5820. Alcavis International, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 3, 2005
Date Received
November 12, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dialyzer Reprocessing System
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

Other clearances by Alcavis International, Inc.

  • K082858 — EXSEPT WC ANTIMICROBIAL SKIN AND WOUND CLEANSER (May 27, 2009)
  • K061467 — EXSEPT WC WOUND CLEANSER (February 15, 2007)

Other clearances for product code LIF

  • K091360 — CLEARFLUX DIALYZER REPROCESSING SYSTEM (November 3, 2010)
  • K040660 — STERICHEK GLUTARALDEHYDE REAGENT STRIPS (November 15, 2004)
  • K033505 — RENACLEAN SH DIALYZER CLEANING SYSTEM (April 27, 2004)
  • K024076 — MAKY 21.1 DIALYZER REPROCESSING SYSTEM (September 26, 2003)
  • K013713 — ARM AUTOMATIC REPROCESSING MACHINE (July 15, 2002)
  • K992016 — AMUKIN D (January 10, 2000)
  • K991851 — RENACLEAR DIALYZER CLEANING SYSTEM (August 30, 1999)
  • K974426 — POTENCY TEST STRIPS, INDICATOR TEST STRIPS (February 10, 1999)
  • K974798 — STERICHEK(TM) RESIDUAL PEROXIDE REAGENT STRPS (March 20, 1998)
  • K970799 — ALEXANDER MANUFACTURING RECHARGEABLE BATTERY (M1/T) (May 14, 1997)

FDA data resources