FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FLUENCY TRACHEOBRONCHIAL STENT GRAFT
K Number: K031041
·
Decision Jun 19, 2003
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
44
Applicant Total
4
Review Days
79
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- FLUENCY TRACHEOBRONCHIAL STENT GRAFT
- K Number
- K031041
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 878.3720
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bard Peripheral Vascular
- Date Received
- April 1, 2003
- Decision Date
- June 19, 2003
- Product Code
- JCT
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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.
Ultraflex Tracheobronchial Stent System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
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