Hansen Medical Magellan Robotic Catheter 6Fr and Accessory Components— 510(k) K151463

Substantially Equivalent

Hansen Medical, Inc.

FDA 510(k) clearance K151463 for Hansen Medical Magellan Robotic Catheter 6Fr and Accessory Components, Substantially Equivalent on 2015-08-18. Applicant: Hansen Medical, Inc..

Clearance details

Applicant: Hansen Medical, Inc.
Product code: Code DRA
Advisory panel: Cardiovascular
Date received: 2015-06-01
Decision date: 2015-08-18
Decision: Substantially Equivalent
Clearance type: Special
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.