510(k) Report

FDA applicant

Vascular Architects, Inc.

San Jose, CA5 decisions2001–20030 recalls

FDA records 5 decisions for Vascular Architects, Inc. (San Jose, CA) from 2001 to 2003: 5 510(k) clearances. Most are in product codes JCT (Prosthesis, Tracheal, Expandable) and ESW (Prosthesis, Esophageal). Its devices cite 5 predicates, 5 of them its own earlier devices. No recall is linked to its devices.

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

FIG. A — Illustration, general and plastic surgery panel, where it files most

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

FDA decisions per year

No FDA decision for Vascular Architects, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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

See the 510(k) Report

Which product codes does it file in?

  • JCTProsthesis, Tracheal, Expandable3decisions
  • ESWProsthesis, Esophageal1decision
  • DWXStripper, Artery, Intraluminal1decision

Who builds on its devices?

Later devices cite its devices 12 times; 5 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K003173Aspire Covered Stent and Delivery CatheterVascular Architects, Inc. · 20015cite it
  • K012544Vascular Architects Aspire Covered Stent and Controlled Expansion Delivery SystemVascular Architects, Inc. · 20015cite it
  • K030567Modification to Vascular Architects Aspire Covered Stent and Contrilled Expansion Delivery SystemVascular Architects, Inc. · 20031cites it
  • K003719Vascular Architects Periscope DeviceVascular Architects, Inc. · 20011cites it

What has FDA decided for it lately?

  • K031641Vascular Architects Aspire Covered Stent and 718 Delivery SystemVascular Architects, Inc. · 2003
  • K030567Modification to Vascular Architects Aspire Covered Stent and Contrilled Expansion Delivery SystemVascular Architects, Inc. · 2003
  • K012544Vascular Architects Aspire Covered Stent and Controlled Expansion Delivery SystemVascular Architects, Inc. · 2001
  • K003173Aspire Covered Stent and Delivery CatheterVascular Architects, Inc. · 2001
  • K003719Vascular Architects Periscope DeviceVascular Architects, Inc. · 2001

All 5 as Vascular Architects, Inc. →