Cleared Traditional

K874542 - TORAY SUPERSELECTIVE GUIDEWIRES

K874542 is the FDA 510(k) clearance for TORAY SUPERSELECTIVE GUIDEWIRES by Toray Industries (America), Inc.. It is a Class 2 Cardiovascular device (product code DQX) cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K874542 · Toray Industries (America), Inc. · Cardiovascular device
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Mar 1988
Decision
125d
Days
Class 2
Risk

K874542 is an FDA 510(k) clearance for the TORAY SUPERSELECTIVE GUIDEWIRES, ADDITIONAL TYPES. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Toray Industries (America), Inc. (New York, US). The FDA issued a Cleared decision on March 7, 1988 after a review of 125 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

Submission Details

510(k) Number K874542 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 1987
Decision Date March 07, 1988
Days to Decision 125 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 125d · This submission: 125d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 502
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K874542.
ACS HI-TORQUE GUIDE WIRES
K874202 · Advanced Cardiovascular Systems, Inc. · Apr 1988
GUIDE WIRE INTRODUCER
K873972 · Target Therapeutics · Apr 1988
CORDIS STEERABLE GUIDEWIRE
K873403 · Cordis Corp. · Mar 1988
ACS 0.025-IN HI-TORQ MODIF J/STAND TELESC GUIDEWIR
K874776 · Advanced Cardiovascular Systems, Inc. · Feb 1988
TELEFLEX STEERABLE GUIDEWIRE
K871850 · Teleflexmedical, Inc. · Jan 1988
STUBBIE STEERABLE GUIDEWIRE
K873543 · Target Therapeutics · Dec 1987