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510(k) K991851

RENACLEAR DIALYZER CLEANING SYSTEM by Minntech Corp. — Product Code LIF

K991851 is an FDA 510(k) premarket notification submitted by Minntech Corp. for the device "RENACLEAR DIALYZER CLEANING SYSTEM". The FDA issued a decision of Substantially Equivalent on August 30, 1999. The device falls under product code LIF (Dialyzer Reprocessing System), a Class II device regulated under 21 CFR 876.5820. Minntech Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 30, 1999
Date Received
June 1, 1999
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 Minntech Corp.

  • K120306 — RAPICIDE OPA-28 (September 27, 2012)
  • K092387 — MEDIVATORS DSD EDGE ENDOSCOPE REPROCESSING SYSTEM (April 5, 2010)
  • K071298 — HF JUNIOR HEMOFILTER (August 8, 2007)
  • K050952 — HPH JUNIOR HIGH PERFORMANCE HEMOCONCENTRATOR (January 31, 2006)
  • K033505 — RENACLEAN SH DIALYZER CLEANING SYSTEM (April 27, 2004)
  • K014016 — ENGUARD CHC DUAL RESERVOIR CARDIOPLEGIA HEATER/COOLER (February 1, 2002)
  • K991137 — ENGUARD PHX CARDIOPLEGIA HEAT EXCHANGER (June 8, 2000)
  • K000028 — RENAFLO II HF 2000 HEMOFILTER (April 4, 2000)
  • K983126 — FIBERFLO HOLLOW FIBER CAPSULE WATER FILTERS (March 8, 1999)
  • K983085 — HEMOCOR HPH 700 HEMOCONCENTRATOR (November 13, 1998)

Other clearances for product code LIF

  • K091360 — CLEARFLUX DIALYZER REPROCESSING SYSTEM (November 3, 2010)
  • K043126 — ASSIST HEADER CLEANER (February 3, 2005)
  • 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)
  • 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