HawkOne Directional Atherectomy System— 510(k) K161361

Substantially Equivalent

Medtronic Vascular, Inc.

FDA 510(k) clearance K161361 for HawkOne Directional Atherectomy System, Substantially Equivalent on 2016-10-14. Applicant: Medtronic Vascular, Inc..

Clearance details

Applicant: Medtronic Vascular, Inc.
Product code: Code MCW
Advisory panel: Cardiovascular
Date received: 2016-05-16
Decision date: 2016-10-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plymouth, MN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MCW

product code MCW

Death: 38
Injury: 1,386
Malfunction: 2,676
Other: 2
Total: 4,102

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.