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510(k) K042984

INTERGARD WOVEN CONNECTOR GRAFT, MODEL IGW0030-10C by Intervascular — Product Code DWF

K042984 is an FDA 510(k) premarket notification submitted by Intervascular for the device "INTERGARD WOVEN CONNECTOR GRAFT, MODEL IGW0030-10C". The FDA issued a decision of Substantially Equivalent on Feb 18, 2005. The device falls under product code DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4210. Intervascular has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Feb 18, 2005
Date Received
Oct 29, 2004
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 Intervascular

  • K103347 — CARDIOROOT WOVEN COLLAGEN COATED VASCULAR PROSTHESES (Feb 2, 2011)
  • K022242 — INTERVASCULAR INTERGARD KNITTED VASCULAR GRAFT SIZER (Aug 14, 2002)
  • K013651 — INTERGARD HEMABRIDGE COLLAGEN COATED VASCULAR PROSTHESIS, INTERGARD AORTIC ARCH (Feb 27, 2002)
  • K990800 — INTERGARD KNITTED ULTRA THIN AND INTERGARD KNITTED COLLAGEN COATED AND HEPARIN B (Jan 8, 2001)
  • K984294 — MODIFICATION OF INTERGARD WOVEN COLLAGEN COATED VASCULAR PROSTHESES (Feb 22, 1999)
  • K983819 — INTERGARD KNITTED ULTRA THIN COLLAGEN COATED VASCULAR GRAFT AND HEMACAROTID PATC (Nov 24, 1998)
  • K970843 — INTERGARD WOVEN COLLAGEN COATED VASCULAR PROSTHESES (Jun 5, 1997)
  • K964625 — HEMAPATCH VASCULAR PATCHES, INTERGARD AND INTERGARD-RS VASCULAR PROSTHESES (May 5, 1997)
  • K921659 — ULTRA LOW POROSITY DACRON WOVEN PATCH (Nov 25, 1992)
  • K913143 — OCHSNER ULP BIFURCATION VASCULAR PROTHESIS (Oct 23, 1991)

Other clearances for product code DWF

  • K260195 — Elongated One-Piece Arterial (EOPA) 3D™ Arterial Cannulae (Apr 23, 2026)
  • K250937 — Venous Return Cannulae (Mar 11, 2026)
  • K260043 — Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR18 (Feb 23, 2026)
  • K253203 — Retrograde Coronary Sinus Perfusion Cannulae (Feb 19, 2026)
  • K253671 — Dual Stage Venous Cannulae (Jan 30, 2026)
  • K253998 — Clearview Intracoronary Shunts (Jan 20, 2026)
  • K253106 — AngioVac Cannula (Oct 24, 2025)
  • K250283 — RAP Femoral Venous Cannulae (Jul 10, 2025)
  • K250610 — Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310) (Jun 27, 2025)
  • K251258 — MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous Cannula (Jun 20, 2025)

FDA data resources