Admiral Xtreme— 510(k) K173515

Substantially Equivalent

Medtronic Vascular

FDA 510(k) clearance K173515 for Admiral Xtreme, Substantially Equivalent on 2018-04-12. Applicant: Medtronic Vascular.

Clearance details

Applicant: Medtronic Vascular
Product code: Code LIT
Advisory panel: Cardiovascular
Date received: 2017-11-14
Decision date: 2018-04-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Rosa, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LIT

product code LIT

Death: 27
Injury: 1,256
Malfunction: 12,127
Total: 13,410

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.