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510(k) K994198

HEMOFEEL-CH, MODELS CH-0.35L, CH-0.6L, CH-1.0L by Toray Industries (America), Inc. — Product Code KDI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 25, 2000
Date Received
December 13, 1999
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 Toray Industries (America), Inc.

  • K042370 — TORAYGUIDE GUIDEWIRE (December 17, 2004)
  • K030050 — TORAYSULFONE DIALYZER, BS-L SERIES (September 29, 2003)
  • K002512 — TORAYSULFONE DIALYZER (October 15, 2001)
  • K942681 — FILTRYZER (June 22, 1995)
  • K935471 — FILTRYZER(TM) (May 19, 1995)
  • K940910 — FILTRYZER (May 4, 1995)
  • K884339 — TORAY FILTRYZER DIALYZERS (March 17, 1989)
  • K883407 — TORAY FILTRYZER BK SERIES (February 27, 1989)
  • K884083 — TORAY VASCULAR PROSTHESIS (January 12, 1989)
  • K882158 — MODIFIED TORAY FILTRYZER DIALYZERS (August 12, 1988)

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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)