CARDIAN II CR45A— 510(k) K861621

Substantially Equivalent

Cardiac Recorders, Ltd.

FDA 510(k) clearance K861621 for CARDIAN II CR45A, Substantially Equivalent on 1986-09-12. Applicant: Cardiac Recorders, Ltd..

Clearance details

Applicant: Cardiac Recorders, Ltd.
Product code: Code DRT
Advisory panel: Cardiovascular
Date received: 1986-04-29
Decision date: 1986-09-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: London, GB

Download summary PDF View on FDA.gov ↗

Adverse events under product code DRT

product code DRT

Death: 4
Total: 4

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.