Cleared Traditional

K042370 - TORAYGUIDE GUIDEWIRE

K042370 is an FDA 510(k) clearance for TORAYGUIDE GUIDEWIRE, manufactured by Toray Industries (America), Inc.. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K042370 · Toray Industries (America), Inc. · Cardiovascular device
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Dec 2004
Decision
108d
Days
Class 2
Risk

K042370 is an FDA 510(k) clearance for the TORAYGUIDE GUIDEWIRE. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Toray Industries (America), Inc. (Bellaire, US). The FDA issued a Cleared decision on December 17, 2004 after a review of 108 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Toray Industries (America), Inc. devices

FDA 510(k) Submission Details - K042370

510(k) Number K042370 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 2004
Decision Date December 17, 2004
Days to Decision 108 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 125d · This submission: 108d
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 689
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K042370.
STEREOTAXIS ENDOVASCULAR GUIDE WIRE
K042854 · Stereotaxis, Inc. · Feb 2005
ASAHI PTCA GUIDE WIRE, J SHAPE SERIES
K043422 · Asahi Intecc Co., Ltd. · Jan 2005
CORDIS STEER-IT DEFLECTING TIP GUIDEWIRE
K040592 · Cordis Corp. · Dec 2004
GUIDEWIRES
K042264 · Rocket Medical Plc · Nov 2004
COMBOWIRE PRESSURE AND FLOW GUIDE WIRE, COMBOTIP PRESSURE AND FLOW GUIDE WIRE
K042996 · Volcano Therapeutics, Inc. · Nov 2004
LUNDERQUIST EXTRA STIFF DOUBLE CURVED EXCHANGE WIRE GUIDE
K042611 · Cook, Inc. · Nov 2004