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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
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Last synced on 17 January 2025 at 11:05 pm
AN
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subpart-d—prosthetic-devices
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JCT
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K062511
View Source
AERO TRACHEOBRONCHIAL STENT SYSTEM, MODEL 90129-2XX
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K062511
510(k) Type
Traditional
Applicant
ALVEOLUS, INC.
Country
United States
FDA Decision
Substantially Equivalent - With Limitations
Decision Date
1/31/2007
Days to Decision
156 days
Submission Type
Summary