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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 K202042
Device Name Reprocessed ViewFlex Xtra Ice Diagnostic Ultrasound Catheter
Applicant
Innovative Health, LLC
1435 N. Hayden Rd.
Suite 100
Scottsdale,  AZ  85257
Applicant Contact Rick Ferreira
Correspondent
Innovative Health, LLC
435 N. Hayden Rd. Suite 100
Scottsdale,  AZ  85257
Correspondent Contact Amanda Babcock
Regulation Number870.1200
Classification Product Code
OWQ  
Subsequent Product Code
OBJ  
Date Received07/23/2020
Decision Date 11/20/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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