ClearanceBrief
Panels › General, Plastic Surgery › Product code JCT · Class 2

Prosthesis, Tracheal, Expandable

Regulation 878.3720

0510(k)s in 12 months (45 all time)
0recalls in 12 months (61 all time)
57recalls that name a 510(k)
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Top companies in JCT

DateFirm and productCodeLinked 510(k)
May 18, 2022Atrium Medical Corporation
iCast Covered Stent System Product Code/Part Number: 85400 85401 85402 85403 85404 85405 85406 85407 85408 85409 85410 85411 85412 85413 85414 85415 85416 85417 85418 85419 85420 85424 85440 85441 85
Open, Classified
JCTK050814
May 18, 2022Atrium Medical Corporation
Atrium Advanta V12 Covered Stent System (OUS only). Product Code/Part Number: 85320 85321 85322 85323 85324 85325 85326 85327 85328 85329 85330 85331 85332 85333 85334 85335 85336 85337 85338 85339 8
Open, Classified
JCTNone listed
Mar 7, 2018SPS Sterilization, Inc
Boston Scientific Wallstent RP Endoprosthesis Tracheobronchial Self-Expanding Stent, 10MM X 94MM | 135CM, resterilized.
Terminated
JCTK152842
Mar 7, 2018SPS Sterilization, Inc
Boston Scientific Wallstent RP Endoprosthesis Tracheobronchial Transhepatic Biliary Self-Expanding Stent, 8MM X 80MM | 75CM, resterilized.
Terminated
JCTK152842
Mar 7, 2018SPS Sterilization, Inc
Boston Scientific Wallstent Endoprosthesis Tracheobronchial Self-Expanding Stent, 24MM X 70MM | 75CM L, resterilized.
Terminated
JCTK152842
Mar 7, 2018SPS Sterilization, Inc
Boston Scientific Wallstent Endoprosthesis Tracheobronchial Self-Expanding Stent, 22MM X 45MM | 75CM L, resterilized.
Terminated
JCTK152842
Mar 7, 2018SPS Sterilization, Inc
Boston Scientific Wallstent Endoprosthesis Tracheobronchial Transhepatic Biliary Self-Expanding Stent, 12MM X 90MM | 75CM L, resterilized.
Terminated
JCTK152842
Jul 7, 2017Atrium Medical Corporation
Atrium iCAST Balloon Expandable Covered Stent; 7mm x 22mm x 120cm; Model/Part Number 85455 (Marketed in U.S. only) Atrium Advanta V12 Balloon Expandable Covered Stent; 7mm x 22mm x 120cm; Model/P
Terminated
JCTK050814
Mar 18, 2016Boston Scientific Corporation
Boston Scientific Ultraflex Tracheobronchial Distal Release Stent System 12mm X 30mm Material Number: M00576550 The stent system is a permanently implanted expandable metal stent designed for pallia
Terminated
JCTK141584
Jul 24, 2015EXP Pharmaceutical Services Corp
Medical Device Exchange Aerosizer Stent Sizing Device; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 90129-501. EXP (repackager), Merit Medical (OEM) Prosthesis, tracheal, expand
Terminated
JCTNone listed
Jul 24, 2015EXP Pharmaceutical Services Corp
Medical Device Exchange 10x40 Airway Stent System; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 90129-209; EXP (repackager), Aero (OEM) Prosthesis, tracheal, expandable
Terminated
JCTNone listed
Jul 24, 2015EXP Pharmaceutical Services Corp
Medical Device Exchange 12x40 Airway Stent System; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 90129-212; EXP (repackager), Aero (OEM) Prosthesis, tracheal, expandable
Terminated
JCTNone listed
Jul 15, 2011Boston Scientific Corporation
Boston Scientific, WALLGRAFT OVER-THE-WIRE, Tracheobronchial Endoprosthesis, Made in IRELAND, Ballybrit Business Park, Galway, IRELAND, STERILE, EO. The WALLGRAFT Tracheobronchial Endoprosthesis is i
Terminated
JCTK000001
K003100 +1
Jul 15, 2011Boston Scientific Corporation
Boston Scientific, WALLSTENT" Endoprosthesis & WALLSTENT" RP Endoprosthesis, Self Expanding Stent, Stent Auto-expanisvel, Made in Ireland, Ballybrit Business Park, Galway, IRELAND, STERILE, EO. Ind
Terminated
JCTK943116
K945494 +3
Aug 31, 2010Boston Scientific Corporation
Boston Scientific Ultraflex Covered Tracheobronchial Stent System - Distal Release (20/6/4.5) Material/UPN/Catalog Number: M00564900
Terminated
JCTK012883
Aug 31, 2010Boston Scientific Corporation
Boston Scientific Ultraflex Covered Tracheobronchial Stent System - Distal Release (18/4/2.5) Material/UPN/Catalog Number: MOO564860
Terminated
JCTK012883
Aug 31, 2010Boston Scientific Corporation
Boston Scientific Ultraflex Covered Tracheobronchial Stent System - Distal Release (16/6/4.5) Material/UPN/Catalog Number: M00564840
Terminated
JCTK012883
Aug 31, 2010Boston Scientific Corporation
Boston Scientific Ultraflex Covered Tracheobronchial Stent System - Distal Release (14/4/2.5) Material/UPN/Catalog Number: M00564800
Terminated
JCTK012883
Aug 31, 2010Boston Scientific Corporation
Boston Scientific Ultraflex Covered Tracheobronchial Stent System -- Distal Release (10/4/2.5) Material/UPN/Catalog Number: M00564760
Terminated
JCTK012883
Aug 31, 2010Boston Scientific Corporation
Boston Scientific Ultraflex Uncovered Tracheobronchial Stent System - Proximal Release (10/4) Material/UPN/Catalog Number: M00564670
Terminated
JCTK012883
Jun 25, 2010Boston Scientific Corporation
Ultraflex Tracheobronchial Stent System. Covered - 14/60 Catalog Number: M00569930. Single Use, Rx only. Boston Scientific, Natick, MA 01760. Indicated for the use in the treatment of tracheobronch
Terminated
JCTK012883
Jun 25, 2010Boston Scientific Corporation
Ultraflex Tracheobronchial Stent System. Uncovered - 14/40 Catalog Number: M00569920. Single Use, Rx only. Boston Scientific, Natick, MA 01760. Indicated for the use in the treatment of tracheobron
Terminated
JCTK012883
Jun 25, 2010Boston Scientific Corporation
Ultraflex Tracheobronchial Stent System. Covered - 20/80/65 Catalog Number: M00569590. Single Use, Rx only. Boston Scientific, Natick, MA 01760. Indicated for the use in the treatment of tracheobro
Terminated
JCTK012883
Jun 25, 2010Boston Scientific Corporation
Ultraflex Tracheobronchial Stent System. Covered - 20/60/45 Catalog Number: M00569580. Single Use, Rx only. Boston Scientific, Natick, MA 01760. Indicated for the use in the treatment of tracheobro
Terminated
JCTK012883
Jun 25, 2010Boston Scientific Corporation
Ultraflex Tracheobronchial Stent System. Covered - 20/40/25 Catalog Number: M00569570. Single Use, Rx only. Boston Scientific, Natick, MA 01760. Indicated for the use in the treatment of tracheobro
Terminated
JCTK012883
Jun 25, 2010Boston Scientific Corporation
Ultraflex Tracheobronchial Stent System. Covered - 18/80/65 Catalog Number: M00569560. Single Use, Rx only. Boston Scientific, Natick, MA 01760. Indicated for the use in the treatment of tracheobro
Terminated
JCTK012883
Jun 25, 2010Boston Scientific Corporation
Ultraflex Tracheobronchial Stent System. Covered - 18/60/45 Catalog Number: M00569550. Single Use, Rx only. Boston Scientific, Natick, MA 01760. Indicated for the use in the treatment of tracheobro
Terminated
JCTK012883
Jun 25, 2010Boston Scientific Corporation
Ultraflex Tracheobronchial Stent System. Covered - 18/40/25 Catalog Number: M00569540. Single Use, Rx only. Boston Scientific, Natick, MA 01760. Indicated for the use in the treatment of tracheobro
Terminated
JCTK012883
Jun 25, 2010Boston Scientific Corporation
Ultraflex Tracheobronchial Stent System. Covered - 16/80/65 Catalog Number: M00569530. Single Use, Rx only. Boston Scientific, Natick, MA 01760. Indicated for the use in the treatment of tracheobro
Terminated
JCTK012883
Jun 25, 2010Boston Scientific Corporation
Ultraflex Tracheobronchial Stent System. Covered - 16/60/45 Catalog Number: M00569520. Single Use, Rx only. Boston Scientific, Natick, MA 01760. Indicated for the use in the treatment of tracheobro
Terminated
JCTK012883
Jun 25, 2010Boston Scientific Corporation
Ultraflex Tracheobronchial Stent System. Covered - 16/40/25 Catalog Number: M00569510. Single Use, Rx only. Boston Scientific, Natick, MA 01760. Indicated for the use in the treatment of tracheobro
Terminated
JCTK012883
Jun 25, 2010Boston Scientific Corporation
Ultraflex Tracheobronchial Stent System. Covered - 18/40/65 Catalog Number: M00569500. Single Use, Rx only. Boston Scientific, Natick, MA 01760. Indicated for the use in the treatment of tracheobro
Terminated
JCTK012883
Jun 25, 2010Boston Scientific Corporation
Ultraflex Tracheobronchial Stent System. Covered - 14/60/45 Catalog Number: M00569490. Single Use, Rx only. Boston Scientific, Natick, MA 01760. Indicated for the use in the treatment of tracheobro
Terminated
JCTK012883
Jun 25, 2010Boston Scientific Corporation
Ultraflex Tracheobronchial Stent System. Covered - 14/40/25 Catalog Number: M00569480. Single Use, Rx only. Boston Scientific, Natick, MA 01760. Indicated for the use in the treatment of tracheobro
Terminated
JCTK012883
Jun 25, 2010Boston Scientific Corporation
Ultraflex Tracheobronchial Stent System. Covered - 12/40/25 Catalog Number: M00569450. Single Use, Rx only. Boston Scientific, Natick, MA 01760. Indicated for the use in the treatment of tracheobro
Terminated
JCTK012883
Jun 25, 2010Boston Scientific Corporation
Ultraflex Tracheobronchial Stent System. Covered - 10/40/25 Catalog Number: M00569430. Single Use, Rx only. Boston Scientific, Natick, MA 01760. Indicated for the use in the treatment of tracheobro
Terminated
JCTK012883
Jun 25, 2010Boston Scientific Corporation
Ultraflex Tracheobronchial Stent System. Covered - 8/40/25 Catalog Number: M00569410. Single Use, Rx only. Boston Scientific, Natick, MA 01760. Indicated for the use in the treatment of tracheobron
Terminated
JCTK012883
Jun 25, 2010Boston Scientific Corporation
Ultraflex Tracheobronchial Stent System. Uncovered - 20/80 Catalog Number: M00569310. Single Use, Rx only. Boston Scientific, Natick, MA 01760. Indicated for the use in the treatment of tracheobron
Terminated
JCTK012883
Jun 25, 2010Boston Scientific Corporation
Ultraflex Tracheobronchial Stent System. Uncovered - 20/60 Catalog Number: M00569300. Single Use, Rx only. Boston Scientific, Natick, MA 01760. Indicated for the use in the treatment of tracheobron
Terminated
JCTK012883
Jun 25, 2010Boston Scientific Corporation
Ultraflex Tracheobronchial Stent System. Uncovered - 20/40 Catalog Number: M00569290. Single Use, Rx only. Boston Scientific, Natick, MA 01760. Indicated for the use in the treatment of tracheobron
Terminated
JCTK012883
Jun 25, 2010Boston Scientific Corporation
Ultraflex Tracheobronchial Stent System. Uncovered - 18/80 Catalog Number: M00569280. Single Use, Rx only. Boston Scientific, Natick, MA 01760. Indicated for the use in the treatment of tracheobron
Terminated
JCTK012883
Jun 25, 2010Boston Scientific Corporation
Ultraflex Tracheobronchial Stent System. Uncovered - 18/60 Catalog Number: M00569270. Single Use, Rx only. Boston Scientific, Natick, MA 01760. Indicated for the use in the treatment of tracheobron
Terminated
JCTK012883
Jun 25, 2010Boston Scientific Corporation
Ultraflex Tracheobronchial Stent System. Uncovered - 18/40 Catalog Number: M00569260. Single Use, Rx only. Boston Scientific, Natick, MA 01760. Indicated for the use in the treatment of tracheobron
Terminated
JCTK012883
Jun 25, 2010Boston Scientific Corporation
Ultraflex Tracheobronchial Stent System. Uncovered - 16/80 Catalog Number: M00569250. Single Use, Rx only. Boston Scientific, Natick, MA 01760. Indicated for the use in the treatment of tracheobron
Terminated
JCTK012883
Jun 25, 2010Boston Scientific Corporation
Ultraflex Tracheobronchial Stent System. Uncovered - 16/60 Catalog Number: M00569240. Single Use, Rx only. Boston Scientific, Natick, MA 01760. Indicated for the use in the treatment of tracheobron
Terminated
JCTK012883
Jun 25, 2010Boston Scientific Corporation
Ultraflex Tracheobronchial Stent System. Uncovered - 16/40 Catalog Number: M00569230. Single Use, Rx only. Boston Scientific, Natick, MA 01760. Indicated for the use in the treatment of tracheobron
Terminated
JCTK012883
Jun 25, 2010Boston Scientific Corporation
Ultraflex Tracheobronchial Stent System. Uncovered - 14/30 Catalog Number: M00569090. Single Use, Rx only. Boston Scientific, Natick, MA 01760. Indicated for the use in the treatment of tracheobron
Terminated
JCTK012883
Jun 25, 2010Boston Scientific Corporation
Ultraflex Tracheobronchial Stent System. Uncovered - 12/30 Catalog Number: M00569080. Single Use, Rx only. Boston Scientific, Natick, MA 01760. Indicated for the use in the treatment of tracheobron
Terminated
JCTK012883
Jun 25, 2010Boston Scientific Corporation
Ultraflex Tracheobronchial Stent System. Uncovered - 10/30 Catalog Number: M00569070. Single Use, Rx only. Boston Scientific, Natick, MA 01760. Indicated for the use in the treatment of tracheobron
Terminated
JCTK012883
Jun 25, 2010Boston Scientific Corporation
Ultraflex Tracheobronchial Stent System. Covered - 12/30/15 Catalog Number: M00569060. Single Use, Rx only. Boston Scientific, Natick, MA 01760. Indicated for the use in the treatment of tracheobro
Terminated
JCTK012883

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