NUCLEUS-X PTV CATHETER— 510(k) DEN080015

Name: FDA 510(k) clearance DEN080015
Creator: U.S. Food and Drug Administration
Published: 2012-06-11

Unknown

NuMED, Inc.

FDA 510(k) clearance DEN080015 for NUCLEUS-X PTV CATHETER, Unknown on 2012-06-11. Applicant: NuMED, Inc.. Device class: 2.

Clearance details

Applicant: NuMED, Inc.
Product code: Code OZT
Device class: Class 2
Regulation: 21 CFR 870.1255
Advisory panel: Cardiovascular
Date received: 2008-12-24
Decision date: 2012-06-11
Decision: Unknown
Clearance type: Post-NSE
Location: Hopkinton, NY, US

View on FDA.gov ↗

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Adverse events under product code OZT

product code OZT

Death: 20
Other: 2
Total: 22

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.