510(k) Report

FDA applicant

Best Vascular, Inc.

Norcross1 decision2000–20000 recalls

FDA records 1 decision for Best Vascular, Inc. (Norcross) in 2000: 1 original PMA approval. All are in product code MOU (Intravascular Radiation Delivery System). 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 Best Vascular, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Best Vascular, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Best Vascular, 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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