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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
510(k) Number K863547
FOIA Releasable 510(k) K863547
Device Name MEDTRONIC MODEL 5455 DISPOSABLE SURGICAL CABLE
Applicant
Medtronic Vascular
Andover Medical
23 Ballard Way
Lawrence,  MA  01843
Applicant Contact ROBERT TETU
Correspondent
Medtronic Vascular
Andover Medical
23 Ballard Way
Lawrence,  MA  01843
Correspondent Contact ROBERT TETU
Regulation Number870.5550
Classification Product Code
DRO  
Date Received09/12/1986
Decision Date 10/31/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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