FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Ultraflex Tracheobronchial Stent System
K Number: K230269
·
Decision Jul 14, 2023
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
44
Applicant Total
231
Review Days
164
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Basic Information
- Device Name
- Ultraflex Tracheobronchial Stent System
- K Number
- K230269
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 878.3720
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Boston Scientific Corporation
- Date Received
- January 31, 2023
- Decision Date
- July 14, 2023
- Product Code
- JCT
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- AN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| JCT | Prosthesis, Tracheal, Expandable | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JCT), ordered by most recent decision date.
Through the Scope Tracheal Stent System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Tracheal Stent System (Y-Shaped)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Tracheal Stent System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
HANAROSTENT Trachea/Bronchium (CCC)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
AEROmini Tracheobronchial Stent System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
WALLSTENT RP ENDOPROSTHESIS TRACHEOBRONCHIAL, WALLSTENT ENDOPROSTHESIS TRACHEOBRONCHIAL
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
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