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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Reprocessed Intravascular Ultrasound Catheter
510(k) Number K210655
Device Name Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter
Applicant
Innovative Health, LLC
1435 N. Hayden Rd.
Suite 100
Scottsdale,  AZ  85257
Applicant Contact Rick Ferreira
Correspondent
Innovative Health, LLC
1435 N. Hayden Rd.
Suite 100
Scottsdale,  AZ  85257
Correspondent Contact Christina Fleming
Regulation Number870.1200
Classification Product Code
OWQ  
Subsequent Product Code
OBJ  
Date Received03/04/2021
Decision Date 05/25/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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