VASCULAR TOOLS 5, CONSISTING OF BRACHIAL ANALYZER 5, CAROTID ANALYZER 5, VASCULAR IMAGER 5 AND INTEGRATED VASCULAR TOOLS— 510(k) K033266

Name: FDA 510(k) clearance K033266
Creator: U.S. Food and Drug Administration
Published: 2004-12-16

Substantially Equivalent

Medical Imaging Applications, LLC

FDA 510(k) clearance K033266 for VASCULAR TOOLS 5, CONSISTING OF BRACHIAL ANALYZER 5, CAROTID ANALYZER 5, VASCULAR IMAGER 5 AND INTEGRATED VASCULAR TOOLS, Substantially Equivalent on 2004-12-16. Applicant: Medical Imaging Applications, LLC. Device class: 2.

Clearance details

Applicant: Medical Imaging Applications, LLC
Product code: Code DQK
Device class: Class 2
Regulation: 21 CFR 870.1425
Advisory panel: Cardiovascular
Date received: 2003-10-09
Decision date: 2004-12-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Coralville, IA, US

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Adverse events under product code DQK

product code DQK

Death: 10
Injury: 225
Malfunction: 2,123
Other: 2
Total: 2,360

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.