510(k) Report

FDA applicant

Cardiovascular Research, Inc.

St Petersburg, FL2 decisions1980–19840 recalls

FDA records 2 decisions for Cardiovascular Research, Inc. (St Petersburg, FL) from 1980 to 1984: 2 510(k) clearances. Most are in product codes DYB (Introducer, Catheter) and DTZ (Oxygenator, Cardiopulmonary Bypass). 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 Cardiovascular Research, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Cardiovascular Research, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Cardiovascular Research, 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?

  • DYBIntroducer, Catheter1decision
  • DTZOxygenator, Cardiopulmonary Bypass1decision

What has FDA decided for it lately?

  • K843118Cannula IntroducerCardiovascular Research, Inc. · 1984
  • K800555Partner Seven Disp. Bubble OxygenatorCardiovascular Research, Inc. · 1980

All 2 as Cardiovascular Research, Inc. →

Other applicant names beginning “Cardiovascular”

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

Cardiovascular Systems, Inc. 29Cardiovascular Imaging Systems, Inc. 19Cardiovascular Diagnostics, Inc. 13Cardiovascular Dynamics, Inc. 11Cardiovascular Devices, Inc. 8Cardiovascular Diagnostic Services 8Cardiovascular Imaging Technologies 7Cardiovascular Imaging Solutions, Ltd. 1Cardiovascular Group, Inc. 1Cardiovascular Innovations 1Cardiovascular System, Inc. 1