Cleared Traditional

K910969 - TORQUE DEVICE FOR A GUIDE WIRE

K910969 is the FDA 510(k) clearance for TORQUE DEVICE FOR A GUIDE WIRE by Terumo Corp.. It is a Class 2 Cardiovascular device (product code DQX) cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K910969 · Terumo Corp. · Cardiovascular device
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May 1991
Decision
71d
Days
Class 2
Risk

K910969 is an FDA 510(k) clearance for the TORQUE DEVICE FOR A GUIDE WIRE. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Terumo Corp. (Somerset, US). The FDA issued a Cleared decision on May 16, 1991 after a review of 71 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Terumo Corp. devices

Submission Details

510(k) Number K910969 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 1991
Decision Date May 16, 1991
Days to Decision 71 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 125d · This submission: 71d
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 486
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K910969.
AMPLANTZ AND BENTSON GUIDEWIRES
K912798 · Meadox Medicals, Div. Boston Scientific Corp. · Sep 1991
OPEN ENDED GUIDEWIRE
K912878 · Lake Region Mfg., Inc. · Sep 1991
.010 HI-TORQUE GUIDE WIRES WITH PRESHAPED TIP
K911460 · Advanced Cardiovascular Systems, Inc. · Jun 1991
CORDIS REFLEX STEERABLE GUIDEWIRE
K905423 · Cordis Corp. · Mar 1991
PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY GUIDEWIRE
K905548 · Mallinckrodt Medical · Feb 1991
TORQUE HANDLE DEVICE FOR GUIDEWIRE
K905639 · Lake Region Mfg., Inc. · Feb 1991