Cleared Traditional

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

K925381 is the FDA 510(k) clearance for ACS HI-TORQUE BALANCE(TM) GUIDE WIRE by Advanced Cardiovascular Systems, Inc.. It is a Class 2 Cardiovascular device (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

Submission Details

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.

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 501
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K925381.
SCIMED(R) 0.038 CONTROLWIRE(TM) PERIPHER GUIDE WIR
K926457 · Scimed Life Systems, Inc. · Apr 1993
CORDIS REFLEX STEERABLE GUIDEWIRE
K930091 · Cordis Corp. · Apr 1993
USCI LUMISILK GUIDE WIRE WITH PRO/PEL COATING
K925074 · C.R. Bard, Inc. · Mar 1993
CORDIS STEERABLE GUIDEWIRE
K925833 · Cordis Corp. · Feb 1993
CORDIS VIERA GUIDEWIRE
K923696 · Cordis Corp. · Feb 1993
ROADRUNNER(TM) WIRE GUIDE, MODIFICATION
K920891 · Cook, Inc. · Dec 1992