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510(k) K840436

HEMASITE/RENALOY -VASCULAR ACCESS SHUNT by Renal Systems, Inc. — Product Code FIQ

K840436 is an FDA 510(k) premarket notification submitted by Renal Systems, Inc. for the device "HEMASITE/RENALOY -VASCULAR ACCESS SHUNT". The FDA issued a decision of Substantially Equivalent on February 21, 1984. The device falls under product code FIQ (Cannula, A-V Shunt), a Class II device regulated under 21 CFR 876.5540. Renal Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 21, 1984
Date Received
February 1, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cannula, A-V Shunt
Device Class
Class II
Regulation Number
876.5540
Review Panel
GU
Submission Type

Other clearances by Renal Systems, Inc.

  • K970648 — PRIMUS HOLLOW FIBER DIALYZER (MODELS 1000,1000S,1350,1350S,2000,2000S) (January 5, 1998)
  • K861730 — ACTRIL FOR KIDNEY MACHINE DISINFECTANT (June 9, 1987)
  • K854011 — RENALFO HEMOFILTER CAVHD (November 5, 1985)
  • K844790 — RENAFLO HEMOCONCENTRATOR (May 23, 1985)
  • K843963 — DIALYSATE CONCENTRATE FOR HEMODIALYSIS-LIQUID/POWD (January 7, 1985)
  • K844108 — RENAL SYSTEMS PERITONEAL ACCESS SYSTEM (January 7, 1985)
  • K842258 — RENATRON (July 6, 1984)
  • K841543 — CONCENTRATE CONDUCTIVITY METER (May 22, 1984)
  • K840182 — RENAPAK CONCENTRATE MIXING SYS. (May 2, 1984)
  • K840437 — HEMASITE ACCESSORIES MODIFICATION (February 21, 1984)

Other clearances for product code FIQ

  • K892887 — ST SERIES SAF-T-SHUNTS ARTERIOVENOUS CANNULA (May 15, 1989)
  • K892666 — SAF-T-SHUNT, S-300 SERIES (May 4, 1989)
  • K892663 — S-100 ALLEN-BROWN SHUNT (May 4, 1989)
  • K844692 — PEDIATRIC SIZED HEMOCATH CATHETER (January 18, 1985)
  • K841791 — PLUME FISTULA NEEDLE (July 9, 1984)
  • K840322 — HEMOFILTRATION CATHETER HF-100 (April 24, 1984)
  • K840415 — HEMOCATH (April 20, 1984)
  • K834358 — PARALLEL DUAL LUMEN SUBCLAVIAN CANNULA (April 2, 1984)
  • K833622 — RENALLOY HEMASITE VASCULAR ACCESS SHUNT (November 29, 1983)
  • K831801 — HEMOCLAV VENOUS CATHETER (July 7, 1983)

FDA data resources