510(k) Report

FDA applicant

Catheffects, LLC

Roseville, CA2 decisions2001–20020 recalls

FDA records 2 decisions for Catheffects, LLC (Roseville, CA) from 2001 to 2002: 2 510(k) clearances. Most are in product codes DQK (Computer, Diagnostic, Programmable) and DRF (Catheter, Electrode Recording, Or Probe…). 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 Catheffects, LLC’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Catheffects, LLC since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Catheffects, LLC 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?

  • DQKComputer, Diagnostic, Programmable1decision
  • DRFCatheter, Electrode Recording, Or Probe, Electrode Recording1decision

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.

  • K011361Desai Vectorcath Mapping Catheter, Desai Vectorcath Connector CableCatheffects, LLC · 20012cite it

What has FDA decided for it lately?

  • K012089Catheffects' Desai Vectorcath Mapping SystemCatheffects, LLC · 2002
  • K011361Desai Vectorcath Mapping Catheter, Desai Vectorcath Connector CableCatheffects, LLC · 2001

All 2 as Catheffects, LLC →