510(k) Report

FDA applicant

Avantec Vascular Corp.

Sunnyvale, CA5 decisions2003–20260 recalls

FDA records 5 decisions for Avantec Vascular Corp. (Sunnyvale, CA) from 2003 to 2026: 5 510(k) clearances. Most are in product codes FGE (Stents, Drains And Dilators For The Biliary…) and MMX (Device, Percutaneous Retrieval). Its devices cite 4 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Avantec Vascular Corporation”.

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 Avantec Vascular Corp.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2017: 12026 (partial year): 1
2007high 1 (2017) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Avantec Vascular Corp.’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?

  • FGEStents, Drains And Dilators For The Biliary Ducts2decisions
  • MMXDevice, Percutaneous Retrieval1decision
  • QEWPeripheral Mechanical Thrombectomy With Aspiration1decision
  • LITCatheter, Angioplasty, Peripheral, Transluminal1decision

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 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.

  • K170987Captus Vascular Retrieval SystemAvantec Vascular Corporation · 20171cites it
  • K030638Duramax .035 Biliary Stent System, Models DML0718-80, DML0718-135, DML0818-80, DML0818-135, DML0918-80…Avantec Vascular Corp. · 20031cites it

What has FDA decided for it lately?

  • K251207Sangria™ Thrombectomy SystemAvantec Vascular Corporation · 2026
  • K170987Captus Vascular Retrieval SystemAvantec Vascular Corporation · 2017
  • K032436Duramax .018 Biliary Stent SystemAvantec Vascular Corp. · 2004
  • K030638Duramax .035 Biliary Stent System, Models DML0718-80, DML0718-135, DML0818-80, DML0818-135, DML0918-80…Avantec Vascular Corp. · 2003
  • K030062Admiral .035 Dilatation Catheter, Models ADL0720-80,ADL0720-135,ADL0820-80…Avantec Vascular Corp. · 2003

All 3 as Avantec Vascular Corp. →All 2 as Avantec Vascular Corporation →