FDA applicant

Vascutech, Inc.

Burlington, MA14 decisions1985–200015 recalls

FDA records 14 decisions for Vascutech, Inc. (Burlington, MA) from 1985 to 2000: 14 510(k) clearances. Most are in product codes MGZ (Valvulotome) and DXE (Catheter, Embolectomy). 15 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 Vascutech, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Vascutech, Inc. since 2007.

Recalls per year

1in 2022

2007high 5 (2015) · low 0 (2007)2026

Class I Class II/III not classified

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

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Other applicant names beginning “Vascutech”

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

VascuTech Medical, LLC 1

Vascutech, Inc.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Vascutech”