FDA applicant

Cardiovascular Dynamics, Inc.

Irvine, CA11 decisions1994–19980 recalls

FDA records 11 decisions for Cardiovascular Dynamics, Inc. (Irvine, CA) from 1994 to 1998: 11 510(k) clearances. Most are in product codes LIT (Catheter, Angioplasty, Peripheral, Transluminal) and KRA (Catheter, Continuous Flush). Its devices cite 17 predicates, 5 of them its own earlier devices. 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 Dynamics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

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

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Cardiovascular Dynamics, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Cardiovascular Dynamics, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Cardiovascular”

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

Cardiovascular Systems, Inc. 29 Cardiovascular Imaging Systems, Inc. 19 Cardiovascular Diagnostics, Inc. 13 Cardiovascular Devices, Inc. 8 Cardiovascular Diagnostic Services 8 Cardiovascular Imaging Technologies 7 Cardiovascular Research, Inc. 2 Cardiovascular Imaging Solutions, Ltd. 1 Cardiovascular Group, Inc. 1 Cardiovascular Innovations 1 Cardiovascular System, Inc. 1

Cardiovascular Dynamics, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Cardiovascular”