FDA Browser
by
Innolitics
Anesthesiology
Review Panel
Miscellaneous
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)
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)
K
08
2284
AERO TRACHEOBRONCHIAL STENT TECHNOLOGY SYSTEM
2
Cleared 510(K)
K
07
1604
ALVEOLUS AERO DV TRACHEOBRONCHIAL STENT SYSTEM
2
Cleared 510(K)
K
06
2511
AERO TRACHEOBRONCHIAL STENT SYSTEM, MODEL 90129-2XX
2
Cleared 510(K)
K
05
0832
FLUENCY PLUS TRACHEOBRONCHIAL STENT GRAFT
2
Cleared 510(K)
K
05
0814
ATRIUM ICAST COVERED STENT
2
Cleared 510(K)
K
04
1269
ATRIUM MEDICAL CORPORATION ICAST COVERED STENT
2
Cleared 510(K)
K
03
3990
ALVEOLUS INC. TB-STS TRACHEOBRONCHIAL STENT SYSTEM
2
Cleared 510(K)
K
03
3053
ALVEOLUS, TB-STS TRACHEOBRONCHIAL STENT SYSTEM
2
Cleared 510(K)
K
03
2744
ALVEOLUS INC., TB-STS TRACHEOBRONCHIAL STENT SYSTEM
2
Cleared 510(K)
K
03
1641
VASCULAR ARCHITECTS ASPIRE COVERED STENT AND 718 DELIVERY SYSTEM
2
Cleared 510(K)
K
03
1041
FLUENCY TRACHEOBRONCHIAL STENT GRAFT
2
Cleared 510(K)
K
03
0947
ALVEOLUS INC., TB-STS TRACHEOBRONCHIAL STENT SYSTEM
2
Cleared 510(K)
K
03
0567
MODIFICATION TO VASCULAR ARCHITECTS ASPIRE COVERED STENT AND CONTRILLED EXPANSION DELIVERY SYSTEM
2
Cleared 510(K)
K
02
4178
VIATORR ENDOPROSTHESIS
2
Cleared 510(K)
K
02
3811
MODIFICATION TO VIABAHN ENDOPROSTHESIS
2
Cleared 510(K)
K
02
1901
WALLGRAFT TRACHEOBRONCHIAL ENDOPROTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM
2
Cleared 510(K)
K
02
1563
INTRACOIL SELF-EXPANDING PERIPHERAL STENT
2
Cleared 510(K)
K
01
3648
VIABAHN ENDOPROSTHESIS
2
Cleared 510(K)
K
01
2544
VASCULAR ARCHITECTS ASPIRE COVERED STENT AND CONTROLLED EXPANSION DELIVERY SYSTEM
2
Cleared 510(K)
K
00
3100
WALLGRAFT TRACHEOBRONCHIAL ENDOPROSTHESIS AND UNISTEP DELIVERY SYSTEM
2
Cleared 510(K)
K
00
0001
WALLGRAFT TRACHEOBRONCHIAL ENDOPROSTHESIS AND UNISTEP DELIVERY SYSTEM
2
Cleared 510(K)
K
00
1257
INTRACOIL STENT
2
Cleared 510(K)
K
99
2510
WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS AND UNISTEP PLUS DELIVERY SYSTEM
2
Cleared 510(K)
K
99
0221
INTRACOIL PERIPHERAL STENT
2
Cleared 510(K)
K
98
2184
WALLSTENT ENDOPROSTHESIS
2
Cleared 510(K)
K
98
0163
WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS AND WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS WITH PERMALUME COVERING
2
Cleared 510(K)
K
96
4121
WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS
2
Cleared 510(K)
K
96
3241
ULTRAFLEX
2
Cleared 510(K)
K
96
1507
WALSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS
2
Cleared 510(K)
K
96
1296
WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS
2
Cleared 510(K)
K
94
5494
WALLSTENT(R) TRACHEOBRONCHIAL ENDOPROSTHESIS
2
Cleared 510(K)
K
93
4116
WALLSTENT TRACHEOBRONCHIAL PROSTHESIS MODIFICATION
2
Cleared 510(K)
K
89
1411
GIANTURCO-WALLACE TRACHEOBRONCHIAL Z STENT
2
Cleared 510(K)
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
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 10 January 2025 at 11:05 pm
AN
/
subpart-d—prosthetic-devices
/
JCT
/
K071604
View Source
ALVEOLUS AERO DV TRACHEOBRONCHIAL STENT SYSTEM
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K071604
510(k) Type
Traditional
Applicant
ALVEOLUS, INC
Country
United States
FDA Decision
Substantially Equivalent - With Limitations
Decision Date
9/19/2007
Days to Decision
99 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
K
12
1048
ULTRAFLEX TRACHEOBRONCHIAL STENT SYSTEM- STERILE UNCOVERED
K
08
3625
AERO DV TRACHEOBRONCHIAL STENT SYSTEM
K
08
2284
AERO TRACHEOBRONCHIAL STENT TECHNOLOGY SYSTEM
K
07
1604
ALVEOLUS AERO DV TRACHEOBRONCHIAL STENT SYSTEM
K
06
2511
AERO TRACHEOBRONCHIAL STENT SYSTEM, MODEL 90129-2XX
K
05
0832
FLUENCY PLUS TRACHEOBRONCHIAL STENT GRAFT
K
05
0814
ATRIUM ICAST COVERED STENT
K
04
1269
ATRIUM MEDICAL CORPORATION ICAST COVERED STENT
K
03
3990
ALVEOLUS INC. TB-STS TRACHEOBRONCHIAL STENT SYSTEM
K
03
3053
ALVEOLUS, TB-STS TRACHEOBRONCHIAL STENT SYSTEM
K
03
2744
ALVEOLUS INC., TB-STS TRACHEOBRONCHIAL STENT SYSTEM
K
03
1641
VASCULAR ARCHITECTS ASPIRE COVERED STENT AND 718 DELIVERY SYSTEM
K
03
1041
FLUENCY TRACHEOBRONCHIAL STENT GRAFT
K
03
0947
ALVEOLUS INC., TB-STS TRACHEOBRONCHIAL STENT SYSTEM
K
03
0567
MODIFICATION TO VASCULAR ARCHITECTS ASPIRE COVERED STENT AND CONTRILLED EXPANSION DELIVERY SYSTEM
K
02
4178
VIATORR ENDOPROSTHESIS
K
02
3811
MODIFICATION TO VIABAHN ENDOPROSTHESIS
K
02
1901
WALLGRAFT TRACHEOBRONCHIAL ENDOPROTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM
K
02
1563
INTRACOIL SELF-EXPANDING PERIPHERAL STENT
K
01
3648
VIABAHN ENDOPROSTHESIS
K
01
2544
VASCULAR ARCHITECTS ASPIRE COVERED STENT AND CONTROLLED EXPANSION DELIVERY SYSTEM
K
00
3100
WALLGRAFT TRACHEOBRONCHIAL ENDOPROSTHESIS AND UNISTEP DELIVERY SYSTEM
K
00
0001
WALLGRAFT TRACHEOBRONCHIAL ENDOPROSTHESIS AND UNISTEP DELIVERY SYSTEM
K
00
1257
INTRACOIL STENT
K
99
2510
WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS AND UNISTEP PLUS DELIVERY SYSTEM
K
99
0221
INTRACOIL PERIPHERAL STENT
K
98
2184
WALLSTENT ENDOPROSTHESIS
K
98
0163
WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS AND WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS WITH PERMALUME COVERING
K
96
4121
WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS
K
96
3241
ULTRAFLEX
K
96
1507
WALSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS
K
96
1296
WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS
K
94
5494
WALLSTENT(R) TRACHEOBRONCHIAL ENDOPROSTHESIS
K
93
4116
WALLSTENT TRACHEOBRONCHIAL PROSTHESIS MODIFICATION
K
89
1411
GIANTURCO-WALLACE TRACHEOBRONCHIAL Z STENT
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
/
K071604
View Source
ALVEOLUS AERO DV TRACHEOBRONCHIAL STENT SYSTEM
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K071604
510(k) Type
Traditional
Applicant
ALVEOLUS, INC
Country
United States
FDA Decision
Substantially Equivalent - With Limitations
Decision Date
9/19/2007
Days to Decision
99 days
Submission Type
Summary