Reprocessed PentaRay Nav eco High-Density Mapping Catheter— 510(k) K190785

Name: FDA 510(k) clearance K190785
Creator: U.S. Food and Drug Administration
Published: 2019-06-25

Substantially Equivalent

Innovative Health, LLC

FDA 510(k) clearance K190785 for Reprocessed PentaRay Nav eco High-Density Mapping Catheter, Substantially Equivalent on 2019-06-25. Applicant: Innovative Health, LLC. Device class: 2.

Clearance details

Applicant: Innovative Health, LLC
Product code: Code NLG
Device class: Class 2
Regulation: 21 CFR 870.1220
Advisory panel: Cardiovascular
Date received: 2019-03-27
Decision date: 2019-06-25
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.