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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 K151617
Device Name Livewire Electrophysiology Catheter
Applicant
Surgical Instrument Service and Savings Inc.(Dba Medline Ren
2747 SW 6th St.
Redmond,  OR  97756
Applicant Contact BRANDI J. PANTELEON
Correspondent
Surgical Instrument Service and Savings Inc.(Dba Medline Ren
2747 SW 6th St.
Redmond,  OR  97756
Correspondent Contact BRANDI J. PANTELEON
Regulation Number870.1220
Classification Product Code
NLH  
Date Received06/15/2015
Decision Date 01/22/2016
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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