Reprocessed Carto Vizigo Bi-Directional Guiding Sheath— 510(k) K212165

Name: FDA 510(k) clearance K212165
Creator: U.S. Food and Drug Administration
Published: 2022-03-10

Substantially Equivalent

Innovative Health, LLC

FDA 510(k) clearance K212165 for Reprocessed Carto Vizigo Bi-Directional Guiding Sheath, Substantially Equivalent on 2022-03-10. Applicant: Innovative Health, LLC. Device class: 2.

Clearance details

Applicant: Innovative Health, LLC
Product code: Code PNE
Device class: Class 2
Regulation: 21 CFR 870.1340
Advisory panel: Cardiovascular
Date received: 2021-07-12
Decision date: 2022-03-10
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.