VASCUTRAK 2, MODELS: V14 AND V18— 510(k) K082343

Name: FDA 510(k) clearance K082343
Creator: U.S. Food and Drug Administration
Published: 2008-09-11

Substantially Equivalent

Ymed, Inc.

FDA 510(k) clearance K082343 for VASCUTRAK 2, MODELS: V14 AND V18, Substantially Equivalent on 2008-09-11. Applicant: Ymed, Inc.. Device class: 2.

Clearance details

Applicant: Ymed, Inc.
Product code: Code PNO
Device class: Class 2
Regulation: 21 CFR 870.1250
Advisory panel: Cardiovascular
Date received: 2008-08-15
Decision date: 2008-09-11
Decision: Substantially Equivalent
Clearance type: Special
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code PNO

product code PNO

Malfunction: 1,646
Total: 1,646

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.