MERCATOR— 510(k) K982384

Substantially Equivalent

Harley Street Software , Ltd.

FDA 510(k) clearance K982384 for MERCATOR, Substantially Equivalent on 1999-01-27. Applicant: Harley Street Software , Ltd..

Clearance details

Applicant: Harley Street Software , Ltd.
Product code: Code DSH
Advisory panel: Cardiovascular
Date received: 1998-07-08
Decision date: 1999-01-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Victoria, B.C., CA

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.