ARTISAN EXTEND CONTROL CATHETER— 510(k) K122275

Substantially Equivalent

Hansen Medical

FDA 510(k) clearance K122275 for ARTISAN EXTEND CONTROL CATHETER, Substantially Equivalent on 2012-08-29. Applicant: Hansen Medical.

Clearance details

Applicant: Hansen Medical
Product code: Code DRA
Advisory panel: Cardiovascular
Date received: 2012-07-30
Decision date: 2012-08-29
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.