FDA.report

510(k) K230269

Device
Ultraflex? Tracheobronchial Stent System
Applicant
Boston Scientific Corporation
510(k) number
K230269
Product code
JCT
Decision
Substantially Equivalent (SESE)
Decision date
2023-07-14
Date received
2023-01-31
Regulation
878.3720
Classification name
Prosthesis, Tracheal, Expandable
Medical specialty
General, Plastic Surgery
Review panel
General, Plastic Surgery
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Catherine Sanford
Address
100 Boston Scientific Way Marlboro MA US 01752 01752

FDA Registration Numbers

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code JCT

510(k)DeviceApplicantDecision date
K220424Through the Scope Tracheal Stent SystemMicro-Tech (Nanjing) Co., Ltd.2022-07-08
K212403Tracheal Stent System (Y-Shaped)Micro-Tech (Nanjing) Co., Ltd.2021-10-30
K202204Tracheal Stent SystemMicro-Tech (Nanjing) Co., Ltd.2021-09-01
K201342HANAROSTENT Trachea/Bronchium (CCC)M.I.Tech Co., Ltd.2020-12-31
K181200AEROmini Tracheobronchial Stent SystemMerit Medical Systems, Inc.2018-09-21
K152842WALLSTENT RP ENDOPROSTHESIS TRACHEOBRONCHIAL, WALLSTENT ENDOPROSTHESIS TRACHEOBRONCHIALBoston Scientific Corporation2016-05-19
K140382AEROMINI TRACHEOBRONCHIAL STENT TECHNOLOGYMerit Medical Systems, Inc.2014-11-25
K140472BONASTENT TRACHEAL / BRONCHIALEndochoice, Inc.2014-10-17
K141584ULTRAFLEX TRACHEOBRONCHIAL COVERED STENT SYSTEMBoston Scientific Corporation2014-10-16
K121048ULTRAFLEX TRACHEOBRONCHIAL STENT SYSTEM- STERILE UNCOVEREDBoston Scientific Corp2012-08-03
K083625AERO DV TRACHEOBRONCHIAL STENT SYSTEMAlveolus, Inc.2009-03-11
K082284AERO TRACHEOBRONCHIAL STENT TECHNOLOGY SYSTEMAlveolus, Inc.2008-11-20
K071604ALVEOLUS AERO DV TRACHEOBRONCHIAL STENT SYSTEMAlveolus, Inc.2007-09-19
K062511AERO TRACHEOBRONCHIAL STENT SYSTEM, MODEL 90129-2XXAlveolus, Inc.2007-01-31
K050832FLUENCY PLUS TRACHEOBRONCHIAL STENT GRAFTBard Peripheral Vascular, Inc.2005-07-07