FDA applicant

Lutonix

New Hope2 decisions2014–20170 recalls

FDA records 2 decisions for Lutonix (New Hope) from 2014 to 2017: 2 original PMA approvals. Most are in product codes PRC (Drug-Coated Peripheral Transluminal…) and ONU (Drug-Eluting Peripheral Transluminal…). 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 Lutonix’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2014high 1 (2014) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Lutonix by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Lutonix

Which product codes does it file in?

What has FDA decided for it lately?