510(k) Report

FDA applicant

Intervascular, Inc.

Clearwater, FL20 decisions1984–20115 recalls

FDA records 20 decisions for Intervascular, Inc. (Clearwater, FL) from 1984 to 2011: 20 510(k) clearances. Most are in product codes DSY (Prosthesis, Vascular Graft, Of 6mm And Greater…) and DXZ (Patch, Pledget And Intracardiac, Petp, Ptfe…). Its devices cite 1 predicate, 0 of them its own earlier devices. 5 recalls are linked to its devices.

FDA’s records also spell it “Intervascular”, “Intervascular Sas”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Intervascular, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2011: 1
2007high 1 (2011) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2026

2009: 22022: 12026 (partial year): 1
2007high 2 (2009) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Intervascular, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Intervascular, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • DSYProsthesis, Vascular Graft, Of 6mm And Greater Diameter17decisions
  • DXZPatch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene2decisions
  • DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K103347Cardioroot Woven Collagen Coated Vascular ProsthesesIntervascular Sas · 20111 recall
  • K042984Intergard Woven Connector Graft, Model IGW0030-10CIntervascular · 2005
  • K022242Intervascular Intergard Knitted Vascular Graft SizerIntervascular · 2002
  • K013651Intergard Hemabridge Collagen Coated Vascular Prosthesis, Intergard Aortic Arch Collagen Coated Vascular…Intervascular · 2002
  • K990800Intergard Knitted Ultra Thin and Intergard Knitted Collagen Coated and Heparin Bonded Vascular ProthesisIntervascular, Inc. · 2001
  • K984294Modification of Intergard Woven Collagen Coated Vascular ProsthesesIntervascular, Inc. · 19991 recall
  • K983819Intergard Knitted Ultra Thin Collagen Coated Vascular Graft and Hemacarotid Patch Ultra ThinIntervascular, Inc. · 19981 recall
  • K970843Intergard Woven Collagen Coated Vascular ProsthesesIntervascular, Inc. · 1997

All 16 as Intervascular, Inc. →All 3 as Intervascular →The one decision as Intervascular Sas →

What has been recalled?

5 recalls linked to its devices; the latest:

  • K103347Cardioroot Woven Collagen Coated Vascular Graft; Model Numbers: 1. HEWROOT0024, 2.…Aug 12, 2026Class II
  • K984294INTERGARD Woven Vascular Graft is a woven polyester graft coated with a bovine collagen.…Apr 29, 2022Class II
  • K964625InterGard Knitted Collagen Coated Vascular prostheses marketed under 510(k) # K964625…Dec 9, 2009
  • K964625InterGard Knitted Collagen Coated Vascular prostheses, Catalog number: IGK1206.…Dec 9, 2009
  • K983819HemaCarotid Patch, Ultrathin, Collagen Coated Knitted Polyester Vascular Patch. Product…Dec 30, 2003