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

Name: FDA 510(k) clearance K122590
Creator: U.S. Food and Drug Administration
Published: 2013-03-01

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. Device class: 2.

Clearance details

Applicant: Terumo Medical Corporation
Product code: Code DQX
Device class: Class 2
Regulation: 21 CFR 870.1330
Advisory panel: Cardiovascular
Date received: 2012-08-24
Decision date: 2013-03-01
Decision: Substantially Equivalent
Clearance type: Special
Location: Somerset, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DQX

view all

K261281 — CROSSLEAD Standard 035 and CROSSLEAD Stiff 0352026-09-03
K253667 — Accoat Guide Wire2026-07-14
K261640 — Merit MAK Nitinol/Gold-Tungsten Guide Wire2026-07-13
K254137 — InQwire Amplatz Guide Wire2026-05-22
K260544 — FMD Peripheral Guide Wire F-14 Flex 6 +4 more2026-03-20

More clearances from Terumo Medical Corporation

view all

K231044 — R2P Navicross2023-07-27
K213531 — TR BAND Radial Compression Device2021-12-20
K193125 — R2P Destination Slender Guiding Sheath2020-01-06
K181237 — Glidesheath Slender Tibial Pedal Kit2018-08-03
K173831 — Glidesheath Slender2018-05-08

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.