FDA applicant

Intervalve, Inc.

Minneapolis, MN5 decisions2013–20151 recall

FDA records 5 decisions for Intervalve, Inc. (Minneapolis, MN) from 2013 to 2015: 5 510(k) clearances. All are in product code OZT (Balloon Aortic Valvuloplasty). Its devices cite 9 predicates, 5 of them its own earlier devices. 1 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 Intervalve, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2015

2013high 2 (2013) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

1in 2014

2013high 1 (2014) · low 0 (2013)2026

Class I Class II/III not classified

FIG. 1 — Intervalve, Inc. by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Intervalve, 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?

What has been recalled?