FDA applicant

Cardiovascular Imaging Systems, Inc.

Sunnyvale, CA19 decisions1989–19970 recalls

FDA records 19 decisions for Cardiovascular Imaging Systems, Inc. (Sunnyvale, CA) from 1989 to 1997: 19 510(k) clearances. Most are in product codes DQO (Catheter, Intravascular, Diagnostic) and ITX (Transducer, Ultrasonic, Diagnostic). 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 Imaging Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Cardiovascular Imaging Systems, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Cardiovascular Imaging Systems, 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 Diagnostics, Inc. 13 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 Imaging Systems, Inc.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Cardiovascular”