K252126
- 510(k) number
- K252126
- Device name
- MitraPatch Mitral Valve Repair System
- Applicant
- Chawla Heart Technologies, LLC CT · US
- Product code
- PAW — Nonabsorbable Expanded Polytetrafluoroethylene Surgi
- Decision date
- 2025-12-04
- Date received
- 2025-07-07
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K252126.pdf
Official FDA record: K252126
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.