Reprocessed Visions PV .035 Digital IVUS Catheter— 510(k) K181126

Name: FDA 510(k) clearance K181126
Creator: U.S. Food and Drug Administration
Published: 2019-01-18

Substantially Equivalent

Innovative Health, LLC

FDA 510(k) clearance K181126 for Reprocessed Visions PV .035 Digital IVUS Catheter, Substantially Equivalent on 2019-01-18. Applicant: Innovative Health, LLC. Device class: 2.

Clearance details

Applicant: Innovative Health, LLC
Product code: Code OWQ
Device class: Class 2
Regulation: 21 CFR 870.1200
Advisory panel: Cardiovascular
Date received: 2018-04-30
Decision date: 2019-01-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Scottsdale, AZ, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.