R2P Radifocus Glidewire Advantage— 510(k) K240818

Substantially Equivalent

Terumo Corporation

FDA 510(k) clearance K240818 for R2P Radifocus Glidewire Advantage, Substantially Equivalent on 2024-11-26. Applicant: Terumo Corporation.

Clearance details

Applicant: Terumo Corporation
Product code: Code DQX
Advisory panel: Cardiovascular
Date received: 2024-03-25
Decision date: 2024-11-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tokyo, JP

Download summary PDF View on FDA.gov ↗

Adverse events under product code DQX

product code DQX

Death: 298
Injury: 4,385
Malfunction: 7,203
Other: 5
Total: 11,891

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.