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510(k) K931586

VITAL-PORT MINI VASCULAR ACCESS SYSTEM by Med Institute, Inc. — Product Code DWF

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
September 27, 1993
Date Received
March 31, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4210
Review Panel
CV
Submission Type

Other clearances by Med Institute, Inc.

  • K990034 — WILSON-COOK COLONIC Z-STENT (April 17, 2000)
  • K982507 — MINI POLYURETHANE CATHETER (September 16, 1998)
  • K981061 — INTRAVASCULAR RETRIEVAL DEVICE (May 26, 1998)
  • K964001 — SWARTZ DOPPLER FLOW PROBE AND MONITOR SYSTEM (April 17, 1998)
  • K971140 — VITAL-PORT INFUSION PAL (November 17, 1997)
  • K970442 — TARGET VITAL-PORT VASCULAR ACCESS SYSTEM (April 30, 1997)
  • K945586 — FLEXIBLE DILATING SHEATH (April 4, 1997)
  • K960698 — NON-CORING NEEDLE (April 15, 1996)
  • K941228 — ENDOLUMINAL ACCESS TUBE (September 27, 1995)
  • K951077 — VITAL-PORT PETIET POLYSULFONE VASCULAR ACCESS SYSTEM (July 31, 1995)

Other clearances for product code DWF

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  • K260043 — Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR18 (February 23, 2026)
  • K253203 — Retrograde Coronary Sinus Perfusion Cannulae (February 19, 2026)
  • K253671 — Dual Stage Venous Cannulae (January 30, 2026)
  • K253998 — Clearview Intracoronary Shunts (January 20, 2026)
  • K253106 — AngioVac Cannula (October 24, 2025)
  • K250283 — RAP Femoral Venous Cannulae (July 10, 2025)
  • K250610 — Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310) (June 27, 2025)
  • K251258 — MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous Cannula (June 20, 2025)
  • K241248 — Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1) (May 31, 2024)