510(k) Report

FDA applicant

Applied Vascular Devices, Inc.

Laguna Hills, CA21 decisions1988–199110 recalls

FDA records 21 decisions for Applied Vascular Devices, Inc. (Laguna Hills, CA) from 1988 to 1991: 21 510(k) clearances. Most are in product codes DXC (Clamp, Vascular) and GCJ (Laparoscope, General & Plastic Surgery). 10 recalls are linked to its devices.

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 Applied Vascular Devices, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Applied Vascular Devices, Inc. since 2007.

Recalls per year

1in 2024

2011: 32012: 22020: 42024: 1
2007high 4 (2020) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Applied Vascular Devices, 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?

  • DXCClamp, Vascular5decisions
  • GCJLaparoscope, General & Plastic Surgery2decisions
  • FGEStents, Drains And Dilators For The Biliary Ducts2decisions
  • DYBIntroducer, Catheter2decisions
  • DXECatheter, Embolectomy2decisions
  • DQYCatheter, Percutaneous1decision

Also: KDC (1), DSS (1), HET (1), GCA (1), DQO (1), DXT (1).

Who builds on its devices?

Later devices cite its devices 7 times; 0 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.

  • K890766Catheter Introducer SheathApplied Vascular Devices, Inc. · 19893cite it
  • K901627Arterial Embolectomy CatheterApplied Vascular Devices, Inc. · 19902cite it
  • K901565Atraumax Surgical Clamp Model Fog-5048, 75MM SideApplied Vascular Devices, Inc. · 19901cites it
  • K910372Intimax Thrombectomy CatheterApplied Vascular Devices, Inc. · 19911cites it

What has FDA decided for it lately?

  • K911730Surgical Obturator with SealApplied Vascular Devices, Inc. · 1991
  • K911589Disposable Surgical Trocar with SealApplied Vascular Devices, Inc. · 1991
  • K910339Avd Intimax Occlusion CatheterApplied Vascular Devices, Inc. · 1991
  • K910372Intimax Thrombectomy CatheterApplied Vascular Devices, Inc. · 19911 recall
  • K911181Intimax (TM) Irrigation CatheterApplied Vascular Devices, Inc. · 1991
  • K910493Avd Intimax Cholangiography CatheterApplied Vascular Devices, Inc. · 1991
  • K903848Diagnostic Intrascular CatheterApplied Vascular Devices, Inc. · 1991
  • K905738Operative Cholangiographic CatheterApplied Vascular Devices, Inc. · 1991

All 21 as Applied Vascular Devices, Inc. →

What has been recalled?

10 recalls linked to its devices; the latest:

  • K910372Syntel Silicone Thrombectomy Catheter, Sterile, Rx Only. Used in vascular grafts and…Apr 17, 2024Class II
  • K883909STEALTH SPRING CLIP 6mm latis (1/4 Force). REF/UDI::A1602/(01)00607915110574 - Product…Jan 31, 2020Class II
  • K883909STEALTH SPRING CLIP 6mm latis (3/4 Force). REF/UDI::A1603/(01)00607915110581 - Product…Jan 31, 2020Class II
  • K883909STEALTH SPRING CLIP 6mm latis (1/4 Force). Non-Sterile…Jan 31, 2020Class II
  • K883909STEALTH SPRING CLIP 6mm latis (1/2 Force). REF/UDI::A1601/(01)00607915110567 - Product…Jan 31, 2020Class II
  • K901627Embolectomy Catheters (Models A44XX, A4FXX, CE0XXXST, and CE0XXX): Model Numbers &…Aug 9, 2012Class II