K253576
- 510(k) number
- K253576
- Device name
- CorVista System® with PCWP Add-On
- Applicant
- Analytics For Life, Inc. MD · US
- Product code
- DQK — Computer, Diagnostic, Programmable
- Decision date
- 2026-07-26
- Date received
- 2025-11-17
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 3.2 MB · U.S. public domain
Also available from FDA: K253576.pdf
Official FDA record: K253576
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.