Cleared Traditional

K925381 - ACS HI-TORQUE BALANCE(TM) GUIDE WIRE

K925381 is an FDA 510(k) clearance for ACS HI-TORQUE BALANCE(TM) GUIDE WIRE, 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 112-day FDA review.

K925381 · Advanced Cardiovascular Systems, Inc. · Cardiovascular device
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Feb 1993
Decision
112d
Days
Class 2
Risk

K925381 is an FDA 510(k) clearance for the ACS HI-TORQUE BALANCE(TM) GUIDE WIRE. 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 February 12, 1993 after a review of 112 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 Advanced Cardiovascular Systems, Inc. devices

FDA 510(k) Submission Details - K925381

510(k) Number K925381 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 1992
Decision Date February 12, 1993
Days to Decision 112 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
13d faster than avg
Panel avg: 125d · This submission: 112d
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 K925381.
CORDIS REFLEX STEERABLE GUIDEWIRE
K930091 · Cordis Corp. · Apr 1993
USCI LUMISILK GUIDE WIRE WITH PRO/PEL COATING
K925074 · C.R. Bard, Inc. · Mar 1993
.25' ULTRA-SELECT GUIDEWIRE
K922060 · Microvena Corp. · Feb 1993
SCHNEIDER HYDRO-SIL GUIDEWIRE
K925804 · Schneider Intl., Ltd. · Feb 1993
CORDIS STEERABLE GUIDEWIRE
K925833 · Cordis Corp. · Feb 1993
HI-TORQUE SPORT-T(TM) GUIDE WIRE
K915554 · Peripheral Systems Group · Feb 1993