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510(k) K842416

DUO FLOW CATHETER-MC 54 by Medical Components, Inc. — Product Code KNZ

K842416 is an FDA 510(k) premarket notification submitted by Medical Components, Inc. for the device "DUO FLOW CATHETER-MC 54". The FDA issued a decision of Substantially Equivalent on July 26, 1984. The device falls under product code KNZ (Accessories, A-V Shunt), a Class II device regulated under 21 CFR 876.5540. Medical Components, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 26, 1984
Date Received
June 20, 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

Other clearances by Medical Components, Inc.

  • K250836 — 14F Duo-Flow® Side X Side Double Lumen Catheter (August 12, 2025)
  • K141633 — PRO-PICC WITH VALVE TECHNOLOGY (September 29, 2014)
  • K132880 — MEDCOMP POWER INJECTABLE SAFETY HUBER NEEDLE (January 8, 2014)
  • K131687 — 6F X 60CM TRIPLE PRO-LINE CT BASIC IR SET (August 16, 2013)
  • K130687 — 2F & 3F VASCU-SHEATH TEARAWAY INTRODUCER (August 15, 2013)
  • K130923 — 5F DIGNITY CT TITANIUM PORT (July 31, 2013)
  • K124046 — VALVED TEARAWAY INTRODUCER GENERATION II (June 3, 2013)
  • K123617 — 3F PRO-PICC (May 15, 2013)
  • K122423 — VASU-PICC (December 12, 2012)
  • K121848 — SPLIT CATH III 24CM SPLIT CATH III 24CM SPLIT CATH III 32CM CATH III 36CM SPLIT (September 21, 2012)

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)
  • K841530 — DOUBLE LUMEN SUBLCAVIAN-FEMORAL (June 25, 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)

FDA data resources