FDA applicant

Cardiosolutions, Inc.

West Bridgewater, MA5 decisions2010–20140 recalls

FDA records 5 decisions for Cardiosolutions, Inc. (West Bridgewater, MA) from 2010 to 2014: 5 510(k) clearances. Most are in product codes DYB (Introducer, Catheter) and DYG (Catheter, Flow Directed). Its devices cite 11 predicates, 3 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Cardiosolutions”.

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 Cardiosolutions, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2010high 1 (2010) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2010.

FIG. 1 — Cardiosolutions, Inc. by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Cardiosolutions, 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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Cardiosolutions, Inc.

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?