QUANTIX OR VESSEL STABILIZER DEVICE— 510(k) K041180

Name: FDA 510(k) clearance K041180
Creator: U.S. Food and Drug Administration
Published: 2004-06-07

Substantially Equivalent

Cardiosonix, Ltd.

FDA 510(k) clearance K041180 for QUANTIX OR VESSEL STABILIZER DEVICE, Substantially Equivalent on 2004-06-07. Applicant: Cardiosonix, Ltd.. Device class: 2.

Clearance details

Applicant: Cardiosonix, Ltd.
Product code: Product code DPW
Device class: Class 2
Regulation: 21 CFR 870.2100
Advisory panel: Cardiovascular
Date received: 2004-05-06
Decision date: 2004-06-07
Decision: Substantially Equivalent
Clearance type: Special
Location: Kfar Saba, IL

Download summary PDF View on FDA.gov ↗

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