PTA-OS SIZING BALLOON, MODEL 360— 510(k) K003320

Name: FDA 510(k) clearance K003320
Creator: U.S. Food and Drug Administration
Published: 2001-05-02

Substantially Equivalent

NuMED, Inc.

FDA 510(k) clearance K003320 for PTA-OS SIZING BALLOON, MODEL 360, Substantially Equivalent on 2001-05-02. Applicant: NuMED, Inc.. Device class: 2.

Clearance details

Applicant: NuMED, Inc.
Product code: Code MJN
Device class: Class 2
Regulation: 21 CFR 870.4450
Advisory panel: Cardiovascular
Date received: 2000-10-24
Decision date: 2001-05-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hopkinton, NY, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code MJN

product code MJN

Death: 31
Injury: 240
Malfunction: 827
Total: 1,098

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.