PERCUSSIVENEB, MODEL PN-2001— 510(k) K003684

Name: FDA 510(k) clearance K003684
Creator: U.S. Food and Drug Administration
Published: 2001-02-23

Substantially Equivalent

Vortran Medical Technology 1, Inc.

FDA 510(k) clearance K003684 for PERCUSSIVENEB, MODEL PN-2001, Substantially Equivalent on 2001-02-23. Applicant: Vortran Medical Technology 1, Inc.. Device class: 2.

Clearance details

Applicant: Vortran Medical Technology 1, Inc.
Product code: Code NHJ
Device class: Class 2
Regulation: 21 CFR 868.5905
Advisory panel: Anesthesiology
Date received: 2000-11-29
Decision date: 2001-02-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Sacramento, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code NHJ

product code NHJ

Death: 7
Total: 7

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.