FDA applicant

Cardio Systems, Inc.

Dallas, TX9 decisions1979–20130 recalls

FDA records 9 decisions for Cardio Systems, Inc. (Dallas, TX) from 1979 to 2013: 9 510(k) clearances. Most are in product codes MCW (Catheter, Peripheral, Atherectomy) and MJJ (Cpb Check Valve, Retrograde Flow, In-Line). 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, cardiovascular panel, where it files most

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

FDA decisions per year

1in 2013

2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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Cardio Systems, 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?