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

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.

Clearance details

Applicant
Innovative Health, LLC
Product code
Code NLG
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Scottsdale, AZ, US
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