510(k) Report

FDA applicant

Applied Vascular

Launa Hills, CA2 decisions1991–19921 recall

FDA records 2 decisions for Applied Vascular (Launa Hills, CA) from 1991 to 1992: 2 510(k) clearances. Most are in product codes FGE (Stents, Drains And Dilators For The Biliary…) and DQO (Catheter, Intravascular, Diagnostic). 1 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, gastroenterology and urology panel, where it files most

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

FDA decisions per year

No FDA decision for Applied Vascular since 2007.

Recalls per year

1in 2012

2012: 1
2007high 1 (2012) · low 0 (2007)2026

Class I Class II/III not classified

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

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Which product codes does it file in?

  • FGEStents, Drains And Dilators For The Biliary Ducts1decision
  • DQOCatheter, Intravascular, Diagnostic1decision

What has FDA decided for it lately?

  • K923699Diagnostic Intravascular CatheterApplied Vascular · 1992
  • K910006Avd Intimax (TM) Biliary CatheterApplied Vascular · 19911 recall

All 2 as Applied Vascular →

What has been recalled?

1 recall linked to its devices; the latest:

  • K910006Biliary Catheters (Models A47XX and CB0XXXXX): Model Numbers & Description: A4752…Aug 9, 2012Class II