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510(k) K152842

WALLSTENT RP ENDOPROSTHESIS TRACHEOBRONCHIAL, WALLSTENT ENDOPROSTHESIS TRACHEOBRONCHIAL by Boston Scientific Corporation — Product Code JCT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 19, 2016
Date Received
September 29, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Tracheal, Expandable
Device Class
Class II
Regulation Number
878.3720
Review Panel
AN
Submission Type

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  • K181200 — AEROmini Tracheobronchial Stent System (September 21, 2018)
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  • K141584 — ULTRAFLEX TRACHEOBRONCHIAL COVERED STENT SYSTEM (October 16, 2014)
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