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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 K221067
Device Name Medline ReNewal Reprocessed St. Jude Medical Livewire Steerable Electrophysiology Catheter
Applicant
Surgical Instrument Service and Savings, Inc.
(Dba Medline Renewal)
1500 NE Hemlock Ave.
Redmond,  OR  97756
Applicant Contact Stephanie Boyle Mays
Correspondent
Surgical Instrument Service and Savings, Inc.
(Dba Medline Renewal)
1500 NE Hemlock Ave.
Redmond,  OR  97756
Correspondent Contact Stephanie Boyle Mays
Regulation Number870.1220
Classification Product Code
NLH  
Date Received04/12/2022
Decision Date 05/31/2023
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
Recalls CDRH Recalls
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