FDA applicant

Cardiovascular Diagnostics, Inc.

Raleigh, NC13 decisions1995–20020 recalls

FDA records 13 decisions for Cardiovascular Diagnostics, Inc. (Raleigh, NC) from 1995 to 2002: 13 510(k) clearances. Most are in product codes GGN (Plasma, Coagulation Control) and KFF (Assay, Heparin). Its devices cite 4 predicates, 0 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, hematology panel, where it files most

How often FDA has decided Cardiovascular Diagnostics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

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

Recalls per year

No recall linked to its devices since 2007.

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

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

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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 Dynamics, Inc. 11 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 Diagnostics, Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Cardiovascular”