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Innolitics
Anesthesiology
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Miscellaneous
Subpart B—Cardiovascular Diagnostic Devices
CFR Sub-Part
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart C—Cardiovascular Monitoring Devices
CFR Sub-Part
Subpart C—Monitoring Devices
CFR Sub-Part
Subpart D—Prosthetic Devices
CFR Sub-Part
JCT
Prosthesis, Tracheal, Expandable
2
Product Code
K
23
0269
Ultraflex™ Tracheobronchial Stent System
2
Cleared 510(K)
K
22
0424
Through the Scope Tracheal Stent System
2
Cleared 510(K)
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)
Show All 45 Submissions
Subpart E—Surgical Devices
CFR Sub-Part
Subpart F—Cardiovascular Therapeutic Devices
CFR Sub-Part
Subpart F—Neurological Therapeutic Devices
CFR Sub-Part
Subpart F—Physical Medicine Therapeutic Devices
CFR Sub-Part
Subpart F—Therapeutic Devices
CFR Sub-Part
Subpart G—Miscellaneous
CFR Sub-Part
Cardiovascular
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Last synced on 16 August 2024 at 11:05 pm
AN
/
subpart-d—prosthetic-devices
/
JCT
/
K230269
View Source
Ultraflex™ Tracheobronchial Stent System
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K230269
510(k) Type
Special
Applicant
Boston Scientific Corporation
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/14/2023
Days to Decision
164 days
Submission Type
Summary
FDA Browser
by
Innolitics
Anesthesiology
Miscellaneous
Subpart B—Cardiovascular Diagnostic Devices
Subpart B—Diagnostic Devices
Subpart C—Cardiovascular Monitoring Devices
Subpart C—Monitoring Devices
Subpart D—Prosthetic Devices
JCT
Prosthesis, Tracheal, Expandable
K
23
0269
Ultraflex™ Tracheobronchial Stent System
K
22
0424
Through the Scope Tracheal Stent System
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
Show All 45 Submissions
Subpart E—Surgical Devices
Subpart F—Cardiovascular Therapeutic Devices
Subpart F—Neurological Therapeutic Devices
Subpart F—Physical Medicine Therapeutic Devices
Subpart F—Therapeutic Devices
Subpart G—Miscellaneous
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
/
subpart-d—prosthetic-devices
/
JCT
/
K230269
View Source
Ultraflex™ Tracheobronchial Stent System
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K230269
510(k) Type
Special
Applicant
Boston Scientific Corporation
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/14/2023
Days to Decision
164 days
Submission Type
Summary