Reprocessed IntellaMap Orion High Resolution Mapping Catheter— 510(k) K211662

Name: FDA 510(k) clearance K211662
Creator: U.S. Food and Drug Administration
Published: 2021-11-18

Substantially Equivalent

Innovative Health, LLC

FDA 510(k) clearance K211662 for Reprocessed IntellaMap Orion High Resolution Mapping Catheter, Substantially Equivalent on 2021-11-18. 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: 2021-06-01
Decision date: 2021-11-18
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.