SilverHawk Peripheral Plaque Excision System, TurboHawk Peripheral Plaque Excision System— 510(k) K170191

Substantially Equivalent

Medtronic Vascular, Inc.

FDA 510(k) clearance K170191 for SilverHawk Peripheral Plaque Excision System, TurboHawk Peripheral Plaque Excision System, Substantially Equivalent on 2017-06-16. Applicant: Medtronic Vascular, Inc..

Clearance details

Applicant: Medtronic Vascular, Inc.
Product code: Code MCW
Advisory panel: Cardiovascular
Date received: 2017-01-23
Decision date: 2017-06-16
Decision: Substantially Equivalent
Clearance type: Special
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.