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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 K240826
Device Name Reprocessed DECANAV™ Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapolar Electrophysiology Catheter
Applicant
Sterilmed, Inc.
5010 Cheshire Pkwy. N
Suite 2
Plymouth,  MN  55446
Applicant Contact Carrie Berge
Correspondent
Sterilmed, Inc.
5010 Cheshire Pkwy. N
Suite 2
Plymouth,  MN  55446
Correspondent Contact Rachel Poltilove
Regulation Number870.1220
Classification Product Code
NLH  
Subsequent Product Code
DRF  
Date Received03/26/2024
Decision Date 10/11/2024
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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