Home / 510(k) Clearances / K994390

510(k) K994390

GAMBRO POLYFLUX 17R, CAPILLARY DIALYZER/ FILTER by Gambro Healthcare — Product Code MSF

K994390 is an FDA 510(k) premarket notification submitted by Gambro Healthcare for the device "GAMBRO POLYFLUX 17R, CAPILLARY DIALYZER/ FILTER". The FDA issued a decision of Substantially Equivalent on October 26, 2000. The device falls under product code MSF (Hemodialyzer, Re-Use, High Flux), a Class II device regulated under 21 CFR 876.5860. Gambro Healthcare has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 26, 2000
Date Received
December 28, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hemodialyzer, Re-Use, High Flux
Device Class
Class II
Regulation Number
876.5860
Review Panel
GU
Submission Type

Other clearances by Gambro Healthcare

  • K990039 — GAMBRO DQM 200 (January 27, 2000)
  • K982413 — COBE ARYLANE H1, H4, H6 & H9 HEMODIALYZERS/FILTERS (April 21, 1999)
  • K982414 — GAMBRO POLYFLUX 11S, 14S, 17S & 21S HEMODIALYZERS/ HEMOFILTERS (March 26, 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 MSF

  • K023615 — GAMBRO POLYFLUX 6 LR, 8 LR AND 10 LR (May 6, 2003)
  • K970679 — ALTRA FLUX 200 HEMODIALYZER (July 23, 1998)
  • K970681 — ALTRA NOVA 200 HEMODIALYZER (July 23, 1998)
  • K970662 — CA CELLULOSE ACETATE HOLLOW FIBER DIALYZER (CA-170/CA-210) (March 11, 1998)
  • K970653 — CAHP HIGH PERFORMANCE CELLULOSE DIACETATE (CAPILLARY, HOLLOW FIBER) (March 11, 1998)
  • K970663 — CT CELLULOSER TRIACETATE HOLLOW FIBER DIALYZER (CT-110G/CT-190G) (January 11, 1998)
  • K970648 — PRIMUS HOLLOW FIBER DIALYZER (MODELS 1000,1000S,1350,1350S,2000,2000S) (January 5, 1998)

FDA data resources