510(k) Report

FDA applicant

Advanced Catheter Therapies, Inc.

Chattanooga, TN3 decisions2013–20160 recalls

FDA records 3 decisions for Advanced Catheter Therapies, Inc. (Chattanooga, TN) from 2013 to 2016: 3 510(k) clearances. Most are in product codes QEY (Mechanical Thrombolysis Catheter) and DQY (Catheter, Percutaneous). 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 Advanced Catheter Therapies, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2013: 12015: 12016: 1
2013high 1 (2013) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

FIG. 1 — Advanced Catheter Therapies, Inc. by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • QEYMechanical Thrombolysis Catheter2decisions
  • DQYCatheter, Percutaneous1decision

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.

  • K153488Occlusion Perfusion CatheterAdvanced Catheter Therapies, Inc. · 20161cites it

What has FDA decided for it lately?

  • K153488Occlusion Perfusion CatheterAdvanced Catheter Therapies, Inc. · 2016
  • K151554Occlusion Perfusion CatheterAdvanced Catheter Therapies, Inc. · 2015
  • K130525Occlusion Perfusion CatheterAdvanced Catheter Therapies, Inc. · 2013

All 3 as Advanced Catheter Therapies, Inc. →