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510(k) K791308

ULDALL SUBCLAVIAN CANNULA SC-100 by Vas-Cath of Canada , Ltd. — Product Code FIQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 3, 1979
Date Received
July 16, 1979
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

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  • K871487 — VAS-CATH PERMANENT SINGLE LUMEN HEMODIALYSIS CATH (June 12, 1987)
  • K863982 — VAS-CATH PERICARDIOCENTESIS CATHETER, SET & TRAY (October 24, 1986)
  • K853283 — VACCESS TM 4006 (August 22, 1985)
  • K844854 — OPTI-FLOW DIGITAL SUBTRACTION ANGIOGRAPHY CAT-KIT (May 21, 1985)
  • K844800 — OPTI-FLOW & OPTI-TORQUE ANGIOGRAPHIC CATHETERS (May 16, 1985)
  • K850009 — EVANS, VAS-CATH EPIDURAL NEEDLE & CATHETER (May 13, 1985)
  • K844336 — VAS-CATH PARALLEL DUAL LUMAN JUGULAR CANNUAL CATH (March 13, 1985)

Other clearances for product code FIQ

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  • 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)
  • K840436 — HEMASITE/RENALOY -VASCULAR ACCESS SHUNT (February 21, 1984)
  • K833622 — RENALLOY HEMASITE VASCULAR ACCESS SHUNT (November 29, 1983)