ESTECH CLEARVIEW MV ATRIAL DEPRESSOR— 510(k) K053021

Name: FDA 510(k) clearance K053021
Creator: U.S. Food and Drug Administration
Published: 2006-01-26

Substantially Equivalent

Estech, Inc.

FDA 510(k) clearance K053021 for ESTECH CLEARVIEW MV ATRIAL DEPRESSOR, Substantially Equivalent on 2006-01-26. Applicant: Estech, Inc.. Device class: 2.

Clearance details

Applicant: Estech, Inc.
Product code: Code DTS
Device class: Class 2
Regulation: 21 CFR 870.4420
Advisory panel: Cardiovascular
Date received: 2005-10-26
Decision date: 2006-01-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Alameda, CA, US

Download summary PDF View on FDA.gov ↗

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