Cleared Traditional

K862360 - ACS HI-TORQUE FLEX-T GUIDE WIRE

K862360 is an FDA 510(k) clearance for ACS HI-TORQUE FLEX-T 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 80-day FDA review.

K862360 · Advanced Cardiovascular Systems, Inc. · Cardiovascular device
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Sep 1986
Decision
80d
Days
Class 2
Risk

K862360 is an FDA 510(k) clearance for the ACS HI-TORQUE FLEX-T GUIDE WIRE. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Advanced Cardiovascular Systems, Inc. (Mountain View, US). The FDA issued a Cleared decision on September 11, 1986 after a review of 80 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 - K862360

510(k) Number K862360 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 1986
Decision Date September 11, 1986
Days to Decision 80 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
45d faster than avg
Panel avg: 125d · This submission: 80d
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 692
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K862360.
TERUMO RADIFOCUS GUIDE WIRE
K863138 · Terumo Medical Corp. · Nov 1986
ADDITIONAL TARGET THERAPEUTICS GUIDE WIRES
K862983 · Target Therapeutics · Sep 1986
UMI STEERABLE TORQUE GUIDE WIRE
K863178 · Universal Medical Instrument Corp. · Sep 1986
ACS WIRE SHAPER
K862567 · Advanced Cardiovascular Systems, Inc. · Sep 1986
THE NAVIGATOR STEERABLE GUIDE WIRE
K860430 · Meadox Surgimed, Inc. · Jul 1986
TORAY SUPERSELECTIVE GUIDEWIRE,SUPERSELEC Y-K TYPE
K861115 · Toray Industries (America), Inc. · Jul 1986