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510(k) K844800

OPTI-FLOW & OPTI-TORQUE ANGIOGRAPHIC CATHETERS by Vas-Cath of Canada , Ltd. — Product Code DQO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 16, 1985
Date Received
December 11, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Diagnostic
Device Class
Class II
Regulation Number
870.1200
Review Panel
CV
Submission Type

Other clearances by Vas-Cath of Canada , Ltd.

  • K875188 — LUER LOCK CONNECTORS / RIDIG P.V.C. (March 2, 1988)
  • K871817 — VAS-CATH PERITONEAL DIALYSIS CATHETER (July 16, 1987)
  • K871487 — VAS-CATH PERMANENT SINGLE LUMEN HEMODIALYSIS CATH (June 12, 1987)
  • K871488 — VAS-CATH PERMANENT DUAL 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)
  • K850009 — EVANS, VAS-CATH EPIDURAL NEEDLE & CATHETER (May 13, 1985)
  • K844434 — VACCESS 3000 SINGLE LUMEN JUGULAR CANNULA-CATH (March 13, 1985)
  • K844336 — VAS-CATH PARALLEL DUAL LUMAN JUGULAR CANNUAL CATH (March 13, 1985)

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