MitraPatch Mitral Valve Repair System— 510(k) K252126
Substantially EquivalentChawla Heart Technologies, LLC
FDA 510(k) clearance K252126 for MitraPatch Mitral Valve Repair System, Substantially Equivalent on 2025-12-04. Applicant: Chawla Heart Technologies, LLC.
Clearance details
- Applicant
- Chawla Heart Technologies, LLC
- Product code
- Code PAW
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bloomfield, CT, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.