510(k) Report

FDA applicant

Bluegrass Vascular Technologies, Inc.

San Antonio, TX1 decision2020–20200 recalls

FDA records 1 decision for Bluegrass Vascular Technologies, Inc. (San Antonio, TX) in 2020: 1 De Novo grant. All are in product code QJH (Reverse Central Venous Recanalization System). No 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, cardiovascular panel, where it files most

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

FDA decisions per year

1in 2020

2020: 1
2020high 1 (2020) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

FIG. 1 — Bluegrass Vascular Technologies, Inc. by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • QJHReverse Central Venous Recanalization System1decision

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • DEN190038Surfacer Inside-Out Access Catheter SystemBluegrass Vascular Technologies, Inc. · 20201cites it

What has FDA decided for it lately?

  • DEN190038Surfacer Inside-Out Access Catheter SystemBluegrass Vascular Technologies, Inc. · 2020

The one decision as Bluegrass Vascular Technologies, Inc. →