510(k) Report

FDA applicant

Cardiovascular Group, Inc.

Lake Oswego, OR1 decision1988–19880 recalls

FDA records 1 decision for Cardiovascular Group, Inc. (Lake Oswego, OR) in 1988: 1 510(k) clearance. All are in product code LDD (Dc-Defibrillator, Low-Energy, (Including…). 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 Group, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

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

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Cardiovascular Group, 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?

  • LDDDc-Defibrillator, Low-Energy, (Including Paddles)1decision

What has FDA decided for it lately?

  • K882235Poly-TacCardiovascular Group, Inc. · 1988

The one decision as Cardiovascular Group, 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 Research, Inc. 2Cardiovascular Imaging Solutions, Ltd. 1Cardiovascular Innovations 1Cardiovascular System, Inc. 1