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510(k) K841530

DOUBLE LUMEN SUBLCAVIAN-FEMORAL by Medical Components, Inc. — Product Code KNZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 25, 1984
Date Received
April 3, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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Other clearances for product code KNZ

  • K842039 — ARGON DUAL LUMEN HEMODIALYSIS, CATHETER (January 29, 1985)
  • K844612 — ACUTE HEMODIALYSIS TRAYS (December 17, 1984)
  • K842864 — VACCESS FEMORAL CANNULA (August 8, 1984)
  • K842416 — DUO FLOW CATHETER-MC 54 (July 26, 1984)
  • K841119 — TOPS DISPOS. INFUSION SET/HEMODIALYSIS (April 20, 1984)
  • K840424 — HEMOCATH REPAIR KIT (March 5, 1984)
  • K840437 — HEMASITE ACCESSORIES MODIFICATION (February 21, 1984)
  • K834510 — RENAFLO AVF SET FOR HEMODIALYSIS (February 4, 1984)
  • K833139 — ACUTE HEMODIALYSIS TRAYS (December 22, 1983)