510(k) Report

FDA applicant

Arterial Vascular Engineering, Inc.

Billerica, MA3 decisions1997–19992 recalls

FDA records 3 decisions for Arterial Vascular Engineering, Inc. (Billerica, MA) from 1997 to 1999: 3 510(k) clearances. Most are in product codes FGE (Stents, Drains And Dilators For The Biliary…) and DQO (Catheter, Intravascular, Diagnostic). 2 recalls are linked to its devices, 2 Class I.

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 Arterial Vascular Engineering, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Arterial Vascular Engineering, Inc. since 2007.

Recalls per year

2in 2013

2013: 2, 2 Class I
2007high 2 (2013) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Arterial Vascular Engineering, Inc. 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
  • DQTOccluder, Catheter Tip1decision

Who builds on its devices?

Later devices cite its devices 4 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.

  • K983927GT1 Floppy, GT1 HI-Per Flex, GT1 Light SupportArterial Vascular Engineering, Inc. · 19994cite it

What has FDA decided for it lately?

  • K984627Ave 4F Siteseer Cardiovascular Angiographic CatheterArterial Vascular Engineering, Inc. · 1999
  • K983927GT1 Floppy, GT1 HI-Per Flex, GT1 Light SupportArterial Vascular Engineering, Inc. · 19992 Class I recalls
  • K971295Ave Bridge Stent SystemArterial Vascular Engineering, Inc. · 1997

All 3 as Arterial Vascular Engineering, Inc. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K983927ZINGER Steerable Guidewire; Models: LVZRLS180J, LVZRLS180S, LVZRMS180J, LVZRMS180S…Oct 21, 2013Class I
  • K983927Zinger Stainless Steel Workhorse Guidewire; Models: ZNGRLS180HJ, ZNGRLS180HS…Oct 21, 2013Class I

Other applicant names beginning “Arterial”

FDA records each applicant name separately; these may or may not be the same firm.

Arterial Vascular Engineering Massachusetts, Inc. 1Arterial Stiffness, Inc. 1