Prosthesis, Tracheal, Expandable

FDA product code JCT · 42 cleared devices

Class 2 General, Plastic Surgery

Regulation: 21 CFR 878.3720
Review panel: AN
Implant: Yes
Life sustaining: Yes
Third party review: No
GMP exempt: No
Clearance span: 1991-12-18 – 2023-07-14

JCT 2023-07-14

Ultraflex™ Tracheobronchial Stent System

Applicant Boston Scientific Corporation

K number K230269

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JCT 2022-07-08

Through the Scope Tracheal Stent System

Applicant Micro-Tech (Nanjing) Co., Ltd.

K number K220424

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JCT 2021-10-30

Tracheal Stent System (Y-Shaped)

Applicant Micro-Tech (Nanjing) Co., Ltd.

K number K212403

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JCT 2021-09-01

Tracheal Stent System

Applicant Micro-Tech (Nanjing) Co., Ltd.

K number K202204

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JCT 2020-12-31

HANAROSTENT Trachea/Bronchium (CCC)

Applicant M.I.Tech Co., Ltd.

K number K201342

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JCT 2018-09-21

AEROmini Tracheobronchial Stent System

Applicant Merit Medical Systems, Inc.

K number K181200

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JCT 2016-05-19

WALLSTENT RP ENDOPROSTHESIS TRACHEOBRONCHIAL, WALLSTENT ENDOPROSTHESIS TRACHEOBRONCHIAL

Applicant Boston Scientific Corporation

K number K152842

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JCT 2012-08-03

ULTRAFLEX TRACHEOBRONCHIAL STENT SYSTEM- STERILE UNCOVERED

Applicant Boston Scientific Corp

K number K121048

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JCT 2009-03-11

AERO DV TRACHEOBRONCHIAL STENT SYSTEM

Applicant Alveolus, Inc.

K number K083625

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JCT 2008-11-20

AERO TRACHEOBRONCHIAL STENT TECHNOLOGY SYSTEM

Applicant Alveolus, Inc.

K number K082284

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JCT 2007-09-19

ALVEOLUS AERO DV TRACHEOBRONCHIAL STENT SYSTEM

Applicant Alveolus, Inc.

K number K071604

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JCT 2007-01-31

AERO TRACHEOBRONCHIAL STENT SYSTEM, MODEL 90129-2XX

Applicant Alveolus, Inc.

K number K062511

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JCT 2005-07-07

FLUENCY PLUS TRACHEOBRONCHIAL STENT GRAFT

Applicant Bard Peripheral Vascular, Inc.

K number K050832

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JCT 2005-05-06

ATRIUM ICAST COVERED STENT

Applicant Atrium Medical Corp.

K number K050814

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JCT 2004-09-14

ATRIUM MEDICAL CORPORATION ICAST COVERED STENT

Applicant Atrium Medical Corp.

K number K041269

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JCT 2004-05-12

ALVEOLUS INC. TB-STS TRACHEOBRONCHIAL STENT SYSTEM

Applicant Alveolus, Inc.

K number K033990

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JCT 2004-02-25

ALVEOLUS, TB-STS TRACHEOBRONCHIAL STENT SYSTEM

Applicant Alveolus, Inc.

K number K033053

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JCT 2003-11-13

ALVEOLUS INC., TB-STS TRACHEOBRONCHIAL STENT SYSTEM

Applicant Alveolus, Inc.

K number K032744

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JCT 2003-08-01

VASCULAR ARCHITECTS ASPIRE COVERED STENT AND 718 DELIVERY SYSTEM

Applicant Vascular Architects, Inc.

K number K031641

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JCT 2003-06-19

FLUENCY TRACHEOBRONCHIAL STENT GRAFT

Applicant Bard Peripheral Vascular

K number K031041

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JCT 2003-05-15

ALVEOLUS INC., TB-STS TRACHEOBRONCHIAL STENT SYSTEM

Applicant Alveolus, Inc.

K number K030947

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JCT 2003-03-24

MODIFICATION TO VASCULAR ARCHITECTS ASPIRE COVERED STENT AND CONTRILLED EXPANSION DELIVERY SYSTEM

Applicant Vascular Architects, Inc.

K number K030567

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JCT 2003-03-07

VIATORR ENDOPROSTHESIS

Applicant W. L. Gore & Associates, Inc.

K number K024178

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JCT 2002-12-10

MODIFICATION TO VIABAHN ENDOPROSTHESIS

Applicant W. L. Gore & Associates, Inc.

K number K023811

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JCT 2002-07-09

WALLGRAFT TRACHEOBRONCHIAL ENDOPROTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM

Applicant Boston Scientific Scimed, Inc.

K number K021901

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JCT 2002-05-31

INTRACOIL SELF-EXPANDING PERIPHERAL STENT

Applicant Sulzer Intratherapeutics, Inc.

K number K021563

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JCT 2002-01-08

VIABAHN ENDOPROSTHESIS

Applicant W. L. Gore & Associates, Inc.

K number K013648

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JCT 2001-11-15

VASCULAR ARCHITECTS ASPIRE COVERED STENT AND CONTROLLED EXPANSION DELIVERY SYSTEM

Applicant Vascular Architects, Inc.

K number K012544

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JCT 2000-12-20

WALLGRAFT TRACHEOBRONCHIAL ENDOPROSTHESIS AND UNISTEP DELIVERY SYSTEM

Applicant Boston Scientific Corp

K number K003100

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JCT 2000-06-05

WALLGRAFT TRACHEOBRONCHIAL ENDOPROSTHESIS AND UNISTEP DELIVERY SYSTEM

Applicant Boston Scientific Scimed, Inc.

K number K000001

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JCT 2000-05-18

INTRACOIL STENT

Applicant Intratherapeutics, Inc.

K number K001257

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JCT 1999-11-18

WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS AND UNISTEP PLUS DELIVERY SYSTEM

Applicant Boston Scientific Corp

K number K992510

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JCT 1999-06-02

INTRACOIL PERIPHERAL STENT

Applicant Intratherapeutics, Inc.

K number K990221

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JCT 1998-07-21

WALLSTENT ENDOPROSTHESIS

Applicant Boston Scientific Scimed, Inc.

K number K982184

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JCT 1998-03-13

WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS AND WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS WITH PERMALUME COVERING

Applicant Boston Scientific Scimed, Inc.

K number K980163

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JCT 1996-12-04

WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS

Applicant Boston Scientific Scimed, Inc.

K number K964121

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JCT 1996-11-14

ULTRAFLEX

Applicant Boston Scientific Corp

K number K963241

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JCT 1996-07-10

WALSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS

Applicant Boston Scientific Scimed, Inc.

K number K961507

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JCT 1996-07-10

WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS

Applicant Boston Scientific Scimed, Inc.

K number K961296

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JCT 1995-03-03

WALLSTENT(R) TRACHEOBRONCHIAL ENDOPROSTHESIS

Applicant Boston Scientific Scimed, Inc.

K number K945494

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JCT 1994-06-02

WALLSTENT TRACHEOBRONCHIAL PROSTHESIS MODIFICATION

Applicant Boston Scientific Scimed, Inc.

K number K934116

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JCT 1991-12-18

GIANTURCO-WALLACE TRACHEOBRONCHIAL Z STENT

Applicant Cook, Inc.

K number K891411

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