Product Code: JCT FDA class 2 21 CFR 878.3720

Prosthesis, Tracheal, Expandable

General, Plastic Surgery

An expandable tracheal prosthesis is a surgically implanted device used to restore tracheal patency following resection, injury, or disease, designed to expand within the airway to maintain an open lumen and support respiratory function. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance. The product code is JCT, regulated under 21 CFR 878.3720, within the General and Plastic Surgery medical specialty. This device is an implant and is classified as life-sustaining.

View on FDA

510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Research product code JCT in seconds

The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

Free to try · every answer cites its records

Ask the Research Assistant See examples

Basic Information

Product Code: JCT
Device Class: FDA class 2
Regulation Number: 878.3720
Medical Specialty: General, Plastic Surgery
Review Panel: AN
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✓

Implant

✓

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 45 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K230269	Ultraflex Tracheobronchial Stent System	Jul 14, 2023	Substantially Equivalent	Boston Scientific Corporation
K220424	Through the Scope Tracheal Stent System	Jul 08, 2022	Substantially Equivalent	Micro-Tech (Nanjing) Co., Ltd.
K212403	Tracheal Stent System (Y-Shaped)	Oct 30, 2021	Substantially Equivalent	Micro-Tech (Nanjing) Co., Ltd.
K202204	Tracheal Stent System	Sep 01, 2021	Substantially Equivalent	Micro-Tech (Nanjing) Co., Ltd.
K201342	HANAROSTENT Trachea/Bronchium (CCC)	Dec 31, 2020	Substantially Equivalent	M.I.Tech Co., Ltd.
K181200	AEROmini Tracheobronchial Stent System	Sep 21, 2018	Substantially Equivalent	Merit Medical Systems, Inc.
K152842	WALLSTENT RP ENDOPROSTHESIS TRACHEOBRONCHIAL, WALLSTENT ENDOPROSTHESIS TRACHEOBRONCHIAL	May 19, 2016	Substantially Equivalent	Boston Scientific Corporation
K140382	AEROMINI TRACHEOBRONCHIAL STENT TECHNOLOGY	Nov 25, 2014	Substantially Equivalent	Merit Medical Systems, Inc.
K140472	BONASTENT TRACHEAL / BRONCHIAL	Oct 17, 2014	Substantially Equivalent	Endochoice, Inc.
K141584	ULTRAFLEX TRACHEOBRONCHIAL COVERED STENT SYSTEM	Oct 16, 2014	Substantially Equivalent	Boston Scientific Corporation
K121048	ULTRAFLEX TRACHEOBRONCHIAL STENT SYSTEM- STERILE UNCOVERED	Aug 03, 2012	Substantially Equivalent	Boston Scientific Corp
K083625	AERO DV TRACHEOBRONCHIAL STENT SYSTEM	Mar 11, 2009	Unknown	Alveolus, Inc.
K082284	AERO TRACHEOBRONCHIAL STENT TECHNOLOGY SYSTEM	Nov 20, 2008	Unknown	Alveolus, Inc.
K071604	ALVEOLUS AERO DV TRACHEOBRONCHIAL STENT SYSTEM	Sep 19, 2007	Unknown	Alveolus, Inc.
K062511	AERO TRACHEOBRONCHIAL STENT SYSTEM, MODEL 90129-2XX	Jan 31, 2007	Unknown	Alveolus, Inc.
K050832	FLUENCY PLUS TRACHEOBRONCHIAL STENT GRAFT	Jul 07, 2005	Substantially Equivalent	Bard Peripheral Vascular, Inc.
K050814	ATRIUM ICAST COVERED STENT	May 06, 2005	Substantially Equivalent	Atrium Medical Corp.
K041269	ATRIUM MEDICAL CORPORATION ICAST COVERED STENT	Sep 14, 2004	Substantially Equivalent	Atrium Medical Corp.
K033990	ALVEOLUS INC. TB-STS TRACHEOBRONCHIAL STENT SYSTEM	May 12, 2004	Substantially Equivalent	Alveolus, Inc.
K033053	ALVEOLUS, TB-STS TRACHEOBRONCHIAL STENT SYSTEM	Feb 25, 2004	Substantially Equivalent	Alveolus, Inc.
K032744	ALVEOLUS INC., TB-STS TRACHEOBRONCHIAL STENT SYSTEM	Nov 13, 2003	Substantially Equivalent	Alveolus, Inc.
K031641	VASCULAR ARCHITECTS ASPIRE COVERED STENT AND 718 DELIVERY SYSTEM	Aug 01, 2003	Substantially Equivalent	Vascular Architects, Inc.
K031041	FLUENCY TRACHEOBRONCHIAL STENT GRAFT	Jun 19, 2003	Substantially Equivalent	Bard Peripheral Vascular
K030947	ALVEOLUS INC., TB-STS TRACHEOBRONCHIAL STENT SYSTEM	May 15, 2003	Substantially Equivalent	Alveolus, Inc.
K030567	MODIFICATION TO VASCULAR ARCHITECTS ASPIRE COVERED STENT AND CONTRILLED EXPANSION DELIVERY SYSTEM	Mar 24, 2003	Substantially Equivalent	Vascular Architects, Inc.
K024178	VIATORR ENDOPROSTHESIS	Mar 07, 2003	Substantially Equivalent	W. L. Gore & Associates, Inc.
K023811	MODIFICATION TO VIABAHN ENDOPROSTHESIS	Dec 10, 2002	Substantially Equivalent	W. L. Gore & Associates, Inc.
K021901	WALLGRAFT TRACHEOBRONCHIAL ENDOPROTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM	Jul 09, 2002	Substantially Equivalent	Boston Scientific Scimed, Inc.
K021563	INTRACOIL SELF-EXPANDING PERIPHERAL STENT	May 31, 2002	Substantially Equivalent	Sulzer Intratherapeutics, Inc.
K013648	VIABAHN ENDOPROSTHESIS	Jan 08, 2002	Substantially Equivalent	W. L. Gore & Associates, Inc.
K012544	VASCULAR ARCHITECTS ASPIRE COVERED STENT AND CONTROLLED EXPANSION DELIVERY SYSTEM	Nov 15, 2001	Substantially Equivalent	Vascular Architects, Inc.
K003100	WALLGRAFT TRACHEOBRONCHIAL ENDOPROSTHESIS AND UNISTEP DELIVERY SYSTEM	Dec 20, 2000	Substantially Equivalent	Boston Scientific Corp
K000001	WALLGRAFT TRACHEOBRONCHIAL ENDOPROSTHESIS AND UNISTEP DELIVERY SYSTEM	Jun 05, 2000	Substantially Equivalent	Boston Scientific Scimed, Inc.
K001257	INTRACOIL STENT	May 18, 2000	Substantially Equivalent	Intratherapeutics, Inc.
K992510	WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS AND UNISTEP PLUS DELIVERY SYSTEM	Nov 18, 1999	Substantially Equivalent	Boston Scientific Corp
K990221	INTRACOIL PERIPHERAL STENT	Jun 02, 1999	Substantially Equivalent	Intratherapeutics, Inc.
K982184	WALLSTENT ENDOPROSTHESIS	Jul 21, 1998	Substantially Equivalent	Boston Scientific Scimed, Inc.
K980163	WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS AND WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS WITH PERMALUME COVERING	Mar 13, 1998	Substantially Equivalent	Boston Scientific Scimed, Inc.
K964121	WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS	Dec 04, 1996	Substantially Equivalent - Subject to Tracking Reg.	Boston Scientific Scimed, Inc.
K963241	ULTRAFLEX	Nov 14, 1996	Substantially Equivalent - Subject to Tracking Reg.	Boston Scientific Corp
K961507	WALSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS	Jul 10, 1996	Substantially Equivalent - Subject to Tracking Reg.	Boston Scientific Scimed, Inc.
K961296	WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS	Jul 10, 1996	Substantially Equivalent - Subject to Tracking Reg.	Boston Scientific Scimed, Inc.
K945494	WALLSTENT(R) TRACHEOBRONCHIAL ENDOPROSTHESIS	Mar 03, 1995	Substantially Equivalent - Subject to Tracking Reg.	Boston Scientific Scimed, Inc.
K934116	WALLSTENT TRACHEOBRONCHIAL PROSTHESIS MODIFICATION	Jun 02, 1994	Substantially Equivalent - Subject to Tracking Reg.	Boston Scientific Scimed, Inc.
K891411	GIANTURCO-WALLACE TRACHEOBRONCHIAL Z STENT	Dec 18, 1991	Substantially Equivalent	Cook, Inc.