Cleared Traditional

K152740 - Radifocus Glidewire

K152740 is an FDA 510(k) clearance for Radifocus Glidewire, manufactured by Ashitaka Factory of Terumo Corp.. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K152740 · Ashitaka Factory of Terumo Corp. · Cardiovascular device
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Nov 2015
Decision
54d
Days
Class 2
Risk

K152740 is an FDA 510(k) clearance for the Radifocus Glidewire. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Ashitaka Factory of Terumo Corp. (Fujinomiya Shizuoka, JP). The FDA issued a Cleared decision on November 16, 2015 after a review of 54 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1330 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ashitaka Factory of Terumo Corp. devices

FDA 510(k) Submission Details - K152740

510(k) Number K152740 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 2015
Decision Date November 16, 2015
Days to Decision 54 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 125d · This submission: 54d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQX Device Classification - Class 2, Special Controls

Product Code DQX Wire, Guide, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1330
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DQX Wire, Guide, Catheter

All 596
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K152740.
Hornet Guidewire, Hornet 10 Guidewire, Hornet 14 Guidewire
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ASAHI Peripheral Guide Wire Series (ASAHI Gladius, ASAHI Halberd, ASAHI Gaia PV)
K150445 · Asahi Intecc Co., Ltd. · Jun 2015