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510(k) K951311

GAMBRO HC 14R HEMOCONCENTRATOR by Cobe Renal Care, Inc. — Product Code KDI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 11, 1996
Date Received
March 22, 1995
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 Cobe Renal Care, Inc.

  • K955497 — GAMBRO FH 22H FIBER HEMOFLTR/PRISMA FH 22H BLOOD TUBING/HEMOFLTR SET (September 25, 1997)
  • K955592 — COBE CENTRYSYSTEM 14 PES HEMODIALYZERS (April 30, 1997)
  • K955487 — GAMBRO POLYFLUX 14, 17, & 21 HEMODIALYZERS (April 18, 1997)
  • K946279 — PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM) (February 10, 1997)
  • K954003 — COBE HEMODYNAMIC RECIRCULATION MONITOR (February 6, 1997)
  • K960474 — COBE CENTRYSYSTEM 600 HG HEMODIALYZERS (August 14, 1996)
  • K944436 — COBE CENTRYSYSTEM CS 200 DIALYZER (January 29, 1996)
  • K952342 — GAMBRO LUNDIA 94-700 & SIGMA 800 HEMODIALYZERS (September 15, 1995)
  • K945747 — GAMBRO LUNDIA 94-600 DIALYZER (September 8, 1995)
  • K945746 — GAMBRO LUNDIA 94-500 DIALYZER (September 8, 1995)

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)