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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 K945494
Device Name WALLSTENT(R) TRACHEOBRONCHIAL ENDOPROSTHESIS
Applicant
Boston Scientific Scimed, Inc.
5905 Nathan Ln.
Plymouth,  MN  55442
Applicant Contact CATHY YOHNK
Correspondent
Boston Scientific Scimed, Inc.
5905 Nathan Ln.
Plymouth,  MN  55442
Correspondent Contact CATHY YOHNK
Regulation Number878.3720
Classification Product Code
JCT  
Date Received11/08/1994
Decision Date 03/03/1995
Decision SE SUBJECT TO TRACKING REG (ST)
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
Recalls CDRH Recalls
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