K181126

Substantially Equivalent

Reprocessed Visions PV .035 Digital IVUS Catheter

Applicant: Innovative Health, LLC
Product code: OWQ
Advisory panel: Cardiovascular
Date received: 2018-04-30
Decision date: 2019-01-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Scottsdale, AZ, US

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