FDA 510(k)
FDA class 2
Substantially Equivalent
🇿🇦 South Africa
OutFlo Aortic Valve Dilatation Balloon Catheter
K Number: K241562
·
Decision Mar 11, 2025
Classifications
1
FEI Numbers
22
Registration Numbers
22
Same Product Code
21
Applicant Total
2
Review Days
284
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Basic Information
- Device Name
- OutFlo Aortic Valve Dilatation Balloon Catheter
- K Number
- K241562
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1255
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Disa Medinotec
- Date Received
- May 31, 2024
- Decision Date
- March 11, 2025
- Product Code
- OZT
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| OZT | Balloon Aortic Valvuloplasty | FDA class 2 | Cardiovascular |
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Other Clearances by Disa Medinotec
| K Number | Device Name | ||
|---|---|---|---|
| K211894 | Trachealator | Nov 24, 2021 | Substantially Equivalent |