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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 K252405
Device Name Medline ReNewal Reprocessed Boston Scientific Dynamic Tip Unidirectional Steerable Diagnostic Catheter
Applicant
Surgical Instrument Service and Savings, Inc.
(Dba Medline Renewal)
1500 NE Hemlock Ave.
Redmond,  OR  97756
Applicant Contact Kelsey LeMay
Correspondent
Surgical Instrument Service and Savings, Inc.
(Dba Medline Renewal)
1500 NE Hemlock Ave.
Redmond,  OR  97756
Correspondent Contact Kelsey LeMay
Regulation Number870.1220
Classification Product Code
NLH  
Date Received07/31/2025
Decision Date 11/26/2025
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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