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510(k) K924437

HEMOSPAL KIT B22 / MULTIFLOW 60 KIT by C.G.H. Medical, Inc. — Product Code KDI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 27, 1994
Date Received
September 1, 1992
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 C.G.H. Medical, Inc.

  • K941708 — COBE CENTRYSYSTEM CS500 DIALYZER (May 12, 1995)
  • K933818 — GAMBRO POLYFLUX II HEMODIALYZERIALYZER HEMODIAFILTER (January 25, 1995)
  • K925522 — CENTRYSYSTEM 3 WITH CHARTS/BP OPTION (September 30, 1994)
  • K920757 — FILTRAL HEMODIALYZERS (August 5, 1994)
  • K931720 — LUNDIA ALPHA 700 HEMODIALYZER (July 7, 1994)
  • K940601 — GAMBRO BICART 720G (March 22, 1994)
  • K915154 — GAMBRO ENGSTROM Y FILTER PKG. ALONE W/ VAR.MODELS (May 27, 1992)
  • K914271 — GAMBRO ENGSTROM Y-FILTER WITH EDITH FLEX (1500F) (April 13, 1992)
  • K915504 — GAMBRO LUNDIA ALPHA HEMODIALYZERS (March 6, 1992)
  • K911603 — HEMOSPAL KIT B22 (August 7, 1991)

Other clearances for product code KDI

  • K252459 — multiFlux 130 (F00013123); multiFlux 160 (F00013124) (February 10, 2026)
  • K253412 — Tablo Hemodialysis System (PN-0008000, PN-0006000U) (January 26, 2026)
  • 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)