Cleared Traditional

K913074 - 0.016 GUIDE WIRE FOR NEUROLOGICAL ENDOSCOPE

K913074 is an FDA 510(k) clearance for 0.016 GUIDE WIRE FOR NEUROLOGICAL ENDOSCOPE, manufactured by Terumo Medical Corp.. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 117-day FDA review.

K913074 · Terumo Medical Corp. · Cardiovascular device
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Nov 1991
Decision
117d
Days
Class 2
Risk

K913074 is an FDA 510(k) clearance for the 0.016 GUIDE WIRE FOR NEUROLOGICAL ENDOSCOPE. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Terumo Medical Corp. (Elkton, US). The FDA issued a Cleared decision on November 5, 1991 after a review of 117 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 Terumo Medical Corp. devices

FDA 510(k) Submission Details - K913074

510(k) Number K913074 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 1991
Decision Date November 05, 1991
Days to Decision 117 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
8d faster than avg
Panel avg: 125d · This submission: 117d
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 541
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K913074.
CORDIS CINCH(R) STEERABLE GUIDEWIRE EXT W/SLX COAT
K914863 · Cordis Corp. · Dec 1991
ONTRAC
K914138 · Lake Region Mfg., Inc. · Dec 1991
REMOVE LABELING RESTRICT FROM GUIDE WIRES
K912293 · Target Therapeutics · Dec 1991
.014 HI-TORQUE FLOPPY PATHFINDER GUIDE WIRE
K913631 · Advanced Cardiovascular Systems, Inc. · Oct 1991
.010 HI-TORQUE PLUS(TM) GUIDE WIRE
K913328 · Advanced Cardiovascular Systems, Inc. · Oct 1991
VASCULAR GUIDE WIRE
K913353 · Advanced Cardiovascular Systems, Inc. · Oct 1991