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FDA Browser
by
Innolitics
Anesthesiology
Review Panel
Cardiovascular Diagnostic Devices
CFR Sub-Part
Cardiovascular Monitoring Devices
CFR Sub-Part
Cardiovascular Therapeutic Devices
CFR Sub-Part
Diagnostic Devices
CFR Sub-Part
Miscellaneous
CFR Sub-Part
Monitoring Devices
CFR Sub-Part
Neurological Therapeutic Devices
CFR Sub-Part
Physical Medicine Therapeutic Devices
CFR Sub-Part
Prosthetic Devices
CFR Sub-Part
JCT
Prosthesis, Tracheal, Expandable
2
Product Code
K
21
2403
Tracheal Stent System (Y-Shaped)
2
Cleared 510(K)
K
20
2204
Tracheal Stent System
2
Cleared 510(K)
K
20
1342
HANAROSTENT Trachea/Bronchium (CCC)
2
Cleared 510(K)
K
18
1200
AEROmini Tracheobronchial Stent System
2
Cleared 510(K)
K
15
2842
WALLSTENT RP ENDOPROSTHESIS TRACHEOBRONCHIAL, WALLSTENT ENDOPROSTHESIS TRACHEOBRONCHIAL
2
Cleared 510(K)
K
14
0382
AEROMINI TRACHEOBRONCHIAL STENT TECHNOLOGY
2
Cleared 510(K)
K
14
0472
BONASTENT TRACHEAL / BRONCHIAL
2
Cleared 510(K)
K
14
1584
ULTRAFLEX TRACHEOBRONCHIAL COVERED STENT SYSTEM
2
Cleared 510(K)
K
12
1048
ULTRAFLEX TRACHEOBRONCHIAL STENT SYSTEM- STERILE UNCOVERED
2
Cleared 510(K)
K
08
3625
AERO DV TRACHEOBRONCHIAL STENT SYSTEM
2
Cleared 510(K)
Show All 43 Submissions
Surgical Devices
CFR Sub-Part
Therapeutic Devices
CFR Sub-Part
Cardiovascular
Review Panel
Chemistry
Review Panel
Dental
Review Panel
Ear, Nose, Throat
Review Panel
Gastroenterology and Urology
Review Panel
General Hospital
Review Panel
Hematology
Review Panel
Immunology
Review Panel
Microbiology
Review Panel
Neurology
Review Panel
Obstetrical and Gynecological
Review Panel
Ophthalmic
Review Panel
Orthopedic
Review Panel
Pathology
Review Panel
Physical Medicine
Review Panel
Radiology
Review Panel
General and Plastic Surgery
Review Panel
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 2 June 2023 at 11:04 pm
AN
/
prosthetic-devices
/
JCT
/
K141584
View Source
ULTRAFLEX TRACHEOBRONCHIAL COVERED STENT SYSTEM
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K141584
510(k) Type
Traditional
Applicant
Boston Scientific Corporation
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/16/2014
Days to Decision
125 days
Submission Type
Summary
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular Diagnostic Devices
Cardiovascular Monitoring Devices
Cardiovascular Therapeutic Devices
Diagnostic Devices
Miscellaneous
Monitoring Devices
Neurological Therapeutic Devices
Physical Medicine Therapeutic Devices
Prosthetic Devices
JCT
Prosthesis, Tracheal, Expandable
K
21
2403
Tracheal Stent System (Y-Shaped)
K
20
2204
Tracheal Stent System
K
20
1342
HANAROSTENT Trachea/Bronchium (CCC)
K
18
1200
AEROmini Tracheobronchial Stent System
K
15
2842
WALLSTENT RP ENDOPROSTHESIS TRACHEOBRONCHIAL, WALLSTENT ENDOPROSTHESIS TRACHEOBRONCHIAL
K
14
0382
AEROMINI TRACHEOBRONCHIAL STENT TECHNOLOGY
K
14
0472
BONASTENT TRACHEAL / BRONCHIAL
K
14
1584
ULTRAFLEX TRACHEOBRONCHIAL COVERED STENT SYSTEM
K
12
1048
ULTRAFLEX TRACHEOBRONCHIAL STENT SYSTEM- STERILE UNCOVERED
K
08
3625
AERO DV TRACHEOBRONCHIAL STENT SYSTEM
Show All 43 Submissions
Surgical Devices
Therapeutic Devices
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
AN
/
prosthetic-devices
/
JCT
/
K141584
View Source
ULTRAFLEX TRACHEOBRONCHIAL COVERED STENT SYSTEM
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K141584
510(k) Type
Traditional
Applicant
Boston Scientific Corporation
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/16/2014
Days to Decision
125 days
Submission Type
Summary