510(k) Report

FDA applicant

Cardio-Dynamics, Inc.

Irvine, CA4 decisions1994–19950 recalls

FDA records 4 decisions for Cardio-Dynamics, Inc. (Irvine, CA) from 1994 to 1995: 4 510(k) clearances. Most are in product codes LIT (Catheter, Angioplasty, Peripheral, Transluminal) and FOZ (Catheter, Intravascular, Therapeutic…). 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 Cardio-Dynamics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Cardio-Dynamics, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Cardio-Dynamics, 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?

  • LITCatheter, Angioplasty, Peripheral, Transluminal3decisions
  • FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days1decision

Who builds on its devices?

Later devices cite its devices 3 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.

  • K954313Focus PC Balloon Dilatation CatheterCardio-Dynamics, Inc. · 19952cite it
  • K931027Bullett Peripheral Infusion CatheterCardio-Dynamics, Inc. · 19941cites it

What has FDA decided for it lately?

  • K954313Focus PC Balloon Dilatation CatheterCardio-Dynamics, Inc. · 1995
  • K945943CVD Periflow (TM) Balloon Dilatation CatheterCardio-Dynamics, Inc. · 1995
  • K942150CVD Small Vessel Balloon Dilation CatheterCardio-Dynamics, Inc. · 1994
  • K931027Bullett Peripheral Infusion CatheterCardio-Dynamics, Inc. · 1994

All 4 as Cardio-Dynamics, Inc. →