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510(k) K921659

ULTRA LOW POROSITY DACRON WOVEN PATCH by Intervascular, Inc. — Product Code DXZ

K921659 is an FDA 510(k) premarket notification submitted by Intervascular, Inc. for the device "ULTRA LOW POROSITY DACRON WOVEN PATCH". The FDA issued a decision of SESP on Nov 25, 1992. The device falls under product code DXZ (Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene), a Class II device regulated under 21 CFR 870.3470. Intervascular, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESP ()
Decision Date
Nov 25, 1992
Date Received
Apr 7, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
Device Class
Class II
Regulation Number
870.3470
Review Panel
CV
Submission Type

Other clearances by Intervascular, Inc.

  • K103347 — CARDIOROOT WOVEN COLLAGEN COATED VASCULAR PROSTHESES (Feb 2, 2011)
  • K042984 — INTERGARD WOVEN CONNECTOR GRAFT, MODEL IGW0030-10C (Feb 18, 2005)
  • 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)
  • K913143 — OCHSNER ULP BIFURCATION VASCULAR PROTHESIS (Oct 23, 1991)

Other clearances for product code DXZ

  • K240775 — PeriBeam® Pericardial Membrane (Apr 18, 2025)
  • K200955 — Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid Patch (Jul 8, 2020)
  • K162506 — PhotoFix Decellularized Bovine Pericardium (Mar 9, 2017)
  • K162579 — VascuCel (Oct 14, 2016)
  • K152127 — CorMatrix Tyke (Feb 4, 2016)
  • K151865 — PremiPatch PTFE Pledget (Oct 27, 2015)
  • K142447 — PERI-GUARD Repair Patch & SUPPLE PERI-GUARD Repair Patch (Jan 7, 2015)
  • K142461 — VASCU-GUARD Peripheral Vascular Patch (Nov 25, 2014)
  • K140789 — CORMATRIX ECM FOR VASCULAR REPAIR (Jul 15, 2014)
  • K130872 — CARDIOCEL (Jan 30, 2014)

FDA data resources