RADIFOCUS GLIDEWIRE ADVANTAGE, RADIFOCUS GLIDEWIRE ADVANTAGE— 510(k) K122590

Substantially Equivalent

Terumo Medical Corporation

FDA 510(k) clearance K122590 for RADIFOCUS GLIDEWIRE ADVANTAGE, RADIFOCUS GLIDEWIRE ADVANTAGE, Substantially Equivalent on 2013-03-01. Applicant: Terumo Medical Corporation.

Clearance details

Applicant: Terumo Medical Corporation
Product code: Code DQX
Advisory panel: Cardiovascular
Date received: 2012-08-24
Decision date: 2013-03-01
Decision: Substantially Equivalent
Clearance type: Special
Location: Somerset, NJ, US

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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.