CorVista System® with PCWP Add-On— 510(k) K253576
Substantially EquivalentAnalytics For Life, Inc.
FDA 510(k) clearance K253576 for CorVista System® with PCWP Add-On, Substantially Equivalent on 2026-07-26. Applicant: Analytics For Life, Inc.. Device class: 2.
Summary
Analytics For Life's CorVista System with PCWP Add-On is filed under DQK, programmable diagnostic computers. The record doesn't expand "PCWP" or describe the add-on's output.
Class II, 21 CFR 870.1425. Cardiovascular is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Analytics For Life filed from Bethesda, Maryland. Review took 251 calendar days (November 17, 2025 to July 26, 2026).
Clearance details
- Applicant
- Analytics For Life, Inc.
- Product code
- Product code DQK
- Device class
- Class 2
- Regulation
- 21 CFR 870.1425
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bethesda, MD, US
Recent devices under product code DQK
view allMore clearances from Analytics For Life, Inc.
view allAdverse events under product code DQK
product code DQK- Death
- 10
- Injury
- 225
- Malfunction
- 2,123
- Other
- 2
- Total
- 2,360
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.