510(k) K871344— PATHFINDER 3, AUTO SURVEYOR AND SURVEYOR

Substantially Equivalent

Reynolds Medical , Ltd.

Clearance details

Applicant: Reynolds Medical , Ltd.
Product code: Code DSI
Advisory panel: Cardiovascular
Date received: 1987-04-06
Decision date: 1987-10-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Herts Sg14 1hz, GB

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.