Cleared Traditional

K861115 - TORAY SUPERSELECTIVE GUIDEWIRE

K861115 is the FDA 510(k) clearance for TORAY SUPERSELECTIVE GUIDEWIRE by Toray Industries (America), Inc.. It is a Class 2 Cardiovascular device (product code DQX) cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K861115 · Toray Industries (America), Inc. · Cardiovascular device
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Jul 1986
Decision
108d
Days
Class 2
Risk

K861115 is an FDA 510(k) clearance for the TORAY SUPERSELECTIVE GUIDEWIRE,SUPERSELEC Y-K TYPE. 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 July 11, 1986 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

Submission Details

510(k) Number K861115 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 1986
Decision Date July 11, 1986
Days to Decision 108 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
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.

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 K861115.
ADDITIONAL TARGET THERAPEUTICS GUIDE WIRES
K862983 · Target Therapeutics · Sep 1986
ACS HI-TORQUE FLEX-T GUIDE WIRE
K862360 · Advanced Cardiovascular Systems, Inc. · Sep 1986
ACS WIRE SHAPER
K862567 · Advanced Cardiovascular Systems, Inc. · Sep 1986
SNAP-ON TORQUER
K862409 · Advanced Cardiovascular Systems, Inc. · Jul 1986
SCHNEIDER-SHILEY WIRE TORQUER
K861606 · Shiley, Inc. · Jun 1986
ACS WHOLEY HI-TORQUE GUIDE WIRE
K861765 · Advanced Cardiovascular Systems, Inc. · May 1986