BodyGuardian Remote Monitoring System (BGRMS v3.0)— 510(k) K243349

Substantially Equivalent

Boston Scientific Cardiac Diagnostic Technologies, Inc.

FDA 510(k) clearance K243349 for BodyGuardian Remote Monitoring System (BGRMS v3.0), Substantially Equivalent on 2026-01-23. Applicant: Boston Scientific Cardiac Diagnostic Technologies, Inc..

Clearance details

Applicant: Boston Scientific Cardiac Diagnostic Technologies, Inc.
Product code: Code DSI
Advisory panel: Cardiovascular
Date received: 2024-10-28
Decision date: 2026-01-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rochester, MN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DSI

product code DSI

Death: 170
Injury: 729
Malfunction: 10,680
Total: 11,579

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.