FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Fortrex 0.035 OTW PTA Balloon Catheter
K Number: K142654
·
Decision Oct 28, 2014
Classifications
1
FEI Numbers
94
Registration Numbers
94
Same Product Code
399
Applicant Total
44
Review Days
40
Basic Information
- Device Name
- Fortrex 0.035 OTW PTA Balloon Catheter
- K Number
- K142654
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Covidien LLC
- Date Received
- September 18, 2014
- Decision Date
- October 28, 2014
- Product Code
- LIT
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | FDA class 2 | Cardiovascular |
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