Cleared Traditional

K861115 - TORAY SUPERSELECTIVE GUIDEWIRE,SUPERSELEC Y-K TYPE

K861115 is an FDA 510(k) clearance for TORAY SUPERSELECTIVE 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.

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

FDA 510(k) Submission Details - K861115

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
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 K861115.
ACS HI-TORQUE FLEX-T GUIDE WIRE
K862360 · Advanced Cardiovascular Systems, Inc. · Sep 1986
ACS WIRE SHAPER
K862567 · Advanced Cardiovascular Systems, Inc. · Sep 1986
THE NAVIGATOR STEERABLE GUIDE WIRE
K860430 · Meadox Surgimed, Inc. · Jul 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