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510(k) K141584

ULTRAFLEX TRACHEOBRONCHIAL COVERED STENT SYSTEM by Boston Scientific Corporation — Product Code JCT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 16, 2014
Date Received
June 13, 2014
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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Other clearances for product code JCT

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  • K201342 — HANAROSTENT Trachea/Bronchium (CCC) (December 31, 2020)
  • K181200 — AEROmini Tracheobronchial Stent System (September 21, 2018)
  • K152842 — WALLSTENT RP ENDOPROSTHESIS TRACHEOBRONCHIAL, WALLSTENT ENDOPROSTHESIS TRACHEOB (May 19, 2016)
  • K140382 — AEROMINI TRACHEOBRONCHIAL STENT TECHNOLOGY (November 25, 2014)
  • K140472 — BONASTENT TRACHEAL / BRONCHIAL (October 17, 2014)
  • K121048 — ULTRAFLEX TRACHEOBRONCHIAL STENT SYSTEM- STERILE UNCOVERED (August 3, 2012)