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510(k) K082284

AERO TRACHEOBRONCHIAL STENT TECHNOLOGY SYSTEM by Alveolus, Inc. — Product Code JCT

K082284 is an FDA 510(k) premarket notification submitted by Alveolus, Inc. for the device "AERO TRACHEOBRONCHIAL STENT TECHNOLOGY SYSTEM". The FDA issued a decision of SESU on November 20, 2008. The device falls under product code JCT (Prosthesis, Tracheal, Expandable), a Class II device regulated under 21 CFR 878.3720. Alveolus, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESU ()
Decision Date
November 20, 2008
Date Received
August 11, 2008
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

Other clearances by Alveolus, Inc.

  • K083625 — AERO DV TRACHEOBRONCHIAL STENT SYSTEM (March 11, 2009)
  • K080838 — ALVEOLUS ALIMAXX-E ESOPHAGEAL STENT SYSTEM (April 24, 2008)
  • K072720 — ALIMAXX-B UNCOVERED BILIARY STENT SYSTEM (April 11, 2008)
  • K071604 — ALVEOLUS AERO DV TRACHEOBRONCHIAL STENT SYSTEM (September 19, 2007)
  • K062511 — AERO TRACHEOBRONCHIAL STENT SYSTEM, MODEL 90129-2XX (January 31, 2007)
  • K060239 — ALEOLUS/ENOVENTIONS,ALIMAXX-E DV ESOPHAGEAL STENT SYSTEM (March 22, 2006)
  • K051621 — ENDOVENTIONS ALIMAXX-E ESOPHAGEAL STENT SYSTEM (July 11, 2005)
  • K033990 — ALVEOLUS INC. TB-STS TRACHEOBRONCHIAL STENT SYSTEM (May 12, 2004)
  • K033053 — ALVEOLUS, TB-STS TRACHEOBRONCHIAL STENT SYSTEM (February 25, 2004)
  • K032744 — ALVEOLUS INC., TB-STS TRACHEOBRONCHIAL STENT SYSTEM (November 13, 2003)

Other clearances for product code JCT

  • K230269 — Ultraflex™ Tracheobronchial Stent System (July 14, 2023)
  • K220424 — Through the Scope Tracheal Stent System (July 8, 2022)
  • K212403 — Tracheal Stent System (Y-Shaped) (October 30, 2021)
  • K202204 — Tracheal Stent System (September 1, 2021)
  • 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)
  • K141584 — ULTRAFLEX TRACHEOBRONCHIAL COVERED STENT SYSTEM (October 16, 2014)

FDA data resources