CARDIOVISTA— 510(k) K902486

Substantially Equivalent

Cardionostics, Inc.

FDA 510(k) clearance K902486 for CARDIOVISTA, Substantially Equivalent on 1990-08-23. Applicant: Cardionostics, Inc..

Clearance details

Applicant: Cardionostics, Inc.
Product code: Code DSH
Advisory panel: Cardiovascular
Date received: 1990-06-04
Decision date: 1990-08-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tustin, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DSH

product code DSH

Death: 3
Injury: 652
Total: 655

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.