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510(k) K982414

GAMBRO POLYFLUX 11S, 14S, 17S & 21S HEMODIALYZERS/ HEMOFILTERS by Gambro Healthcare — Product Code KDI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 26, 1999
Date Received
July 13, 1998
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 Gambro Healthcare

  • K994390 — GAMBRO POLYFLUX 17R, CAPILLARY DIALYZER/ FILTER (October 26, 2000)
  • K990039 — GAMBRO DQM 200 (January 27, 2000)
  • K982413 — COBE ARYLANE H1, H4, H6 & H9 HEMODIALYZERS/FILTERS (April 21, 1999)
  • K980386 — HOSPAL MULTIFLOW 100, MULTIFLOW 100 KITS A0 (A0,A0/B AND A0/0), MULTIFLOW 100 KI (February 24, 1999)
  • K982760 — COBE C HEMODIALYSIS DELIVERY SYSTEM , COBE CARTRIDGE BLOOD TUBING SET (November 4, 1998)
  • K982818 — HOSPAL TIPSTOP (October 21, 1998)
  • K974899 — GAMBRO CENTRAL WATER TREATMENT SYSTEM CWP 100 - WRO H (September 23, 1998)
  • K981681 — PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM) (August 11, 1998)
  • K981085 — GAMBRO HEMODIALYSIS WATER TREATMENT SYSTEM (May 18, 1998)
  • K970253 — COBE CENTRYSYSTEM 3 DIALYSIS CONTROL UNIT/COBE CARTRIDGE BLOOD TUBING SET (September 26, 1997)

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)