CARDISUNY 501 A— 510(k) K852829

Substantially Equivalent

Atrix

FDA 510(k) clearance K852829 for CARDISUNY 501 A, Substantially Equivalent on 1986-02-26. Applicant: Atrix.

Clearance details

Applicant: Atrix
Product code: Code DPS
Advisory panel: Cardiovascular
Date received: 1985-07-03
Decision date: 1986-02-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Portland, OR, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DPS

product code DPS

Death: 7
Total: 7

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.