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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Pacemaker, Temporary
510(k) Number K171253
Device Name Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipolar Temporary Pacing Lead, Streamline 6495 Bipolar Temporary Myocardial Pacing Lead, Streamline 6500 Unipolar Temporary Myocardial Pacing Lead
Applicant
Medtronic
1851 E. Deere Ave.
Santa Ana,  CA  92705
Applicant Contact Debra Taitague
Correspondent
Medtronic
1851 E. Deere Ave.
Santa Ana,  CA  92705
Correspondent Contact Debra Taitague
Regulation Number870.3680
Classification Product Code
LDF  
Date Received04/28/2017
Decision Date 05/25/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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