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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Tracheal, Expandable
510(k) Number K121048
Device Name ULTRAFLEX TRACHEOBRONCHIAL STENT SYSTEM- STERILE UNCOVERED
Applicant
Boston Scientific Corp
100 Boston Scientific Way
Marlboro,  MA  01752
Applicant Contact JANIS F TARANTO
Correspondent
Boston Scientific Corp
100 Boston Scientific Way
Marlboro,  MA  01752
Correspondent Contact JANIS F TARANTO
Regulation Number878.3720
Classification Product Code
JCT  
Date Received04/06/2012
Decision Date 08/03/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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