Hansen Medical Magellan Robotic Catheter 9Fr— 510(k) K160919

Substantially Equivalent

Hansen Medical, Inc.

FDA 510(k) clearance K160919 for Hansen Medical Magellan Robotic Catheter 9Fr, Substantially Equivalent on 2016-09-20. Applicant: Hansen Medical, Inc..

Clearance details

Applicant: Hansen Medical, Inc.
Product code: Code DRA
Advisory panel: Cardiovascular
Date received: 2016-04-04
Decision date: 2016-09-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountain View, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DRA

product code DRA

Death: 156
Injury: 3,133
Malfunction: 6,266
Total: 9,555

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.