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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular Occluding, Temporary
510(k) Number K153530
Device Name Bridge Occlusion Balloon
Applicant
Spectranetics, Inc.
9965 Federal Dr.
Colorado Springs,  CO  80921
Applicant Contact Christopher McLellan
Correspondent
Spectranetics, Inc.
9965 Federal Dr.
Colorado Springs,  CO  80921
Correspondent Contact Christopher McLellan
Regulation Number870.4450
Classification Product Code
MJN  
Date Received12/09/2015
Decision Date 02/05/2016
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
Recalls CDRH Recalls
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