Cleared Traditional

K992169 - ACS HI-TORQUE CROSS-IT 400XT GUIDE WIRE

K992169 is an FDA 510(k) clearance for ACS HI-TORQUE CROSS-IT 400XT 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 122-day FDA review.

K992169 · Advanced Cardiovascular Systems, Inc. · Cardiovascular device
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Oct 1999
Decision
122d
Days
Class 2
Risk

K992169 is an FDA 510(k) clearance for the ACS HI-TORQUE CROSS-IT 400XT 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 October 28, 1999 after a review of 122 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 - K992169

510(k) Number K992169 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 1999
Decision Date October 28, 1999
Days to Decision 122 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
3d faster than avg
Panel avg: 125d · This submission: 122d
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 K992169.
ABD VARISOFT STEERABLE GUIDE WIRE AND ABD VARISOFT GUIDE WIRE EXTENSION
K981936 · Advanced Biomedical Devices, Inc. · Feb 2000
ATW MARKER WIRE STEERABLE GUIDEWIRE
K994358 · Cordis Corp. · Jan 2000
BARD HYDROPHILIC COATED GUIDE WIRES
K993000 · C.R. Bard, Inc. · Nov 1999
.010 SILVERSPEED HYDROPOPHILIC GUIDEWIRE, .014 SILVERSPED HYDROPHILIC GUIDEWIRE, .016 SILVERSPEED HYDROPHILIC GUIDEWI
K993257 · Micro Therapeutics, Inc. · Oct 1999
AGILITY STEERABLE GUIDEWIRE
K991646 · Cordis Neurovascular, Inc. · Sep 1999
MEDTRONIC GT2 FUSION GUIDE WIRES
K992237 · Medtronic Vascular · Sep 1999