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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Recording, Electrode, Reprocessed
510(k) Number K211276
Device Name Reprocessed Dynamic Tip and XT Steerable Diagnostic Electrophysiology 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 Number870.1220
Classification Product Code
NLH  
Subsequent Product Code
DRF  
Date Received04/27/2021
Decision Date 09/15/2021
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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