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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Angiography, Reprocessed
510(k) Number K231015
Device Name Reprocessed Super Torque and Super Torque Plus Diagnostic Angiographic Catheters
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 Amanda Babcock
Regulation Number870.1200
Classification Product Code
NLI  
Date Received04/10/2023
Decision Date 07/01/2024
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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