FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
KardiaPSI Balloon Catheter
K Number: K253855
·
Decision May 6, 2026
Classifications
1
FEI Numbers
22
Registration Numbers
22
Same Product Code
21
Applicant Total
1
Review Days
154
Basic Information
- Device Name
- KardiaPSI Balloon Catheter
- K Number
- K253855
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1255
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Intervention Tech, Inc. ; dba Corvention
- Date Received
- December 3, 2025
- Decision Date
- May 6, 2026
- 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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