Pure Flow External Counter-Pulsation Device— 510(k) K173483

Name: FDA 510(k) clearance K173483
Creator: U.S. Food and Drug Administration
Published: 2018-05-30

Substantially Equivalent

Xtreem Pulse, LLC

FDA 510(k) clearance K173483 for Pure Flow External Counter-Pulsation Device, Substantially Equivalent on 2018-05-30. Applicant: Xtreem Pulse, LLC. Device class: 2.

Clearance details

Applicant: Xtreem Pulse, LLC
Product code: Code DRN
Device class: Class 2
Regulation: 21 CFR 870.5225
Advisory panel: Cardiovascular
Date received: 2017-11-13
Decision date: 2018-05-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New York, NY, US

Download summary PDF View on FDA.gov ↗

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