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510(k) K884326

FILTRAL TM 8 HEMODIALYZER by Hospal Medical Corp. — Product Code KDI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 5, 1988
Date Received
October 14, 1988
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 Hospal Medical Corp.

  • K893742 — FILTRAL TM 20 HEMODIALYZER/FILTER (July 24, 1989)
  • K884365 — MULTIFLOW(TM) 60 KIT (December 8, 1988)
  • K883307 — CARDIOFLOW 100 HEMOCONCENTRATOR/PREPARATION KIT (October 12, 1988)
  • K872767 — FILTRAL 10, FILTRAL 12, FILTRAL 16 HEMODIALYZER (December 29, 1987)
  • K871218 — MONITRAL S GS HEMODIALYSIS SINGLE PATIENT UNIT (April 30, 1987)
  • K863961 — HOSPAL BIOSPAL 1800S (December 17, 1986)
  • K863592 — DISSCAP 80E, 110E, 140E, 160E (September 25, 1986)
  • K861156 — HOSPAL DIALYSATE FOR CAVHD (September 23, 1986)
  • K861230 — MONITRAL S (April 25, 1986)
  • K854951 — PLUME Y SET (January 8, 1986)

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  • 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)