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510(k) K970648

PRIMUS HOLLOW FIBER DIALYZER (MODELS 1000,1000S,1350,1350S,2000,2000S) by Renal Systems, Inc. — Product Code MSF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 5, 1998
Date Received
February 20, 1997
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 Renal Systems, Inc.

  • K861730 — ACTRIL FOR KIDNEY MACHINE DISINFECTANT (June 9, 1987)
  • K854011 — RENALFO HEMOFILTER CAVHD (November 5, 1985)
  • K844790 — RENAFLO HEMOCONCENTRATOR (May 23, 1985)
  • K844108 — RENAL SYSTEMS PERITONEAL ACCESS SYSTEM (January 7, 1985)
  • K843963 — DIALYSATE CONCENTRATE FOR HEMODIALYSIS-LIQUID/POWD (January 7, 1985)
  • K842258 — RENATRON (July 6, 1984)
  • K841543 — CONCENTRATE CONDUCTIVITY METER (May 22, 1984)
  • K840182 — RENAPAK CONCENTRATE MIXING SYS. (May 2, 1984)
  • K840436 — HEMASITE/RENALOY -VASCULAR ACCESS SHUNT (February 21, 1984)
  • K840437 — HEMASITE ACCESSORIES MODIFICATION (February 21, 1984)

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  • K970681 — ALTRA NOVA 200 HEMODIALYZER (July 23, 1998)
  • K970679 — ALTRA FLUX 200 HEMODIALYZER (July 23, 1998)
  • K970653 — CAHP HIGH PERFORMANCE CELLULOSE DIACETATE (CAPILLARY, HOLLOW FIBER) (March 11, 1998)
  • K970662 — CA CELLULOSE ACETATE HOLLOW FIBER DIALYZER (CA-170/CA-210) (March 11, 1998)
  • K970663 — CT CELLULOSER TRIACETATE HOLLOW FIBER DIALYZER (CT-110G/CT-190G) (January 11, 1998)