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510(k) K000028

RENAFLO II HF 2000 HEMOFILTER by Minntech Corp. — Product Code KDI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 4, 2000
Date Received
January 5, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dialyzer, High Permeability With Or Without Sealed Dialysate System
Device Class
Class II
Regulation Number
876.5860
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)
  • K991851 — RENACLEAR DIALYZER CLEANING SYSTEM (August 30, 1999)
  • K983126 — FIBERFLO HOLLOW FIBER CAPSULE WATER FILTERS (March 8, 1999)
  • K983085 — HEMOCOR HPH 700 HEMOCONCENTRATOR (November 13, 1998)

Other clearances for product code KDI

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  • K253518 — FX CorAL 40; FX CorAL 50 (December 18, 2025)
  • K243920 — Purema H Hemoconcentrator - Pediatric (September 19, 2025)
  • K250508 — AK 98 Dialysis Machine (955607) (August 1, 2025)
  • K243237 — 2008T HD SYS. CDX BLUESTAR (191124); 2008T HD SYS. CDX W/bibag BLUESTAR (191126) (June 13, 2025)
  • K243505 — 5008X Hemodialysis System (May 30, 2025)
  • K242155 — DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO) (May 15, 2025)
  • K243264 — DHF 0.2 Hemoconcentrator (DHF 02); DHF 0.6 Hemoconcentrator (DHF 06); SH 14 Hemo (April 25, 2025)
  • K242053 — FX CorAL 40 (F00009214); FX CorAL 50 (F00009215) (March 21, 2025)