Cleared Traditional

K911460 - .010 HI-TORQUE GUIDE WIRES WITH PRESHAPED TIP

K911460 is an FDA 510(k) clearance for .010 HI-TORQUE GUIDE WIRES WITH PRESHAP..., manufactured by Advanced Cardiovascular Systems, Inc.. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K911460 · Advanced Cardiovascular Systems, Inc. · Cardiovascular device
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Jun 1991
Decision
83d
Days
Class 2
Risk

K911460 is an FDA 510(k) clearance for the .010 HI-TORQUE GUIDE WIRES WITH PRESHAPED TIP. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Advanced Cardiovascular Systems, Inc. (Santa Clara, US). The FDA issued a Cleared decision on June 25, 1991 after a review of 83 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 Advanced Cardiovascular Systems, Inc. devices

FDA 510(k) Submission Details - K911460

510(k) Number K911460 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 1991
Decision Date June 25, 1991
Days to Decision 83 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
42d faster than avg
Panel avg: 125d · This submission: 83d
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 690
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K911460.
OPEN ENDED GUIDEWIRE
K912878 · Lake Region Mfg., Inc. · Sep 1991
SCHNEIDER MAGNUM PERIPHERAL RECANAL GUIDEWIRE
K912156 · Schneider Intl., Ltd. · Sep 1991
MAGNUM-MEIER RECANALIZATION GUIDEWIRE
K911547 · Schneider Intl., Ltd. · Jul 1991
TORQUE DEVICE FOR A GUIDE WIRE
K910969 · Terumo Corp. · May 1991
ULTRA-SELECT PTCA GUIDEWIRE
K910280 · Microvena Corp. · Apr 1991
CORDIS REFLEX STEERABLE GUIDEWIRE
K905423 · Cordis Corp. · Mar 1991