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510(k) K030947

ALVEOLUS INC., TB-STS TRACHEOBRONCHIAL STENT SYSTEM by Alveolus, Inc. — Product Code JCT

K030947 is an FDA 510(k) premarket notification submitted by Alveolus, Inc. for the device "ALVEOLUS INC., TB-STS TRACHEOBRONCHIAL STENT SYSTEM". The FDA issued a decision of Substantially Equivalent on May 15, 2003. 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
SESE (Substantially Equivalent)
Decision Date
May 15, 2003
Date Received
March 26, 2003
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)
  • K082284 — AERO TRACHEOBRONCHIAL STENT TECHNOLOGY SYSTEM (November 20, 2008)
  • 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)

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