Cleared Traditional

K864585 - ACS HI-TORQUE FLOPPY GUIDE WIRE

K864585 is the FDA 510(k) clearance for ACS HI-TORQUE FLOPPY 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 18-day FDA review.

K864585 · Advanced Cardiovascular Systems, Inc. · Cardiovascular device
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Dec 1986
Decision
18d
Days
Class 2
Risk

K864585 is an FDA 510(k) clearance for the ACS HI-TORQUE FLOPPY GUIDE WIRE, 0.018 INCH. 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 December 5, 1986 after a review of 18 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

Submission Details

510(k) Number K864585 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 1986
Decision Date December 05, 1986
Days to Decision 18 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
107d faster than avg
Panel avg: 125d · This submission: 18d
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 K864585.
TARGET THERAPEUTICS TAPER GUIDE WIRE
K864316 · Target Therapeutics · Mar 1987
AMPLATZ MOVEABLE CORE GUIDEWIRE
K864058 · Lake Region Mfg., Inc. · Feb 1987
SCHNEIDER-SHILEY GUIDE WIRE
K864787 · Shiley, Inc. · Feb 1987
TERUMO RADIFOCUS GUIDE WIRE
K863138 · Terumo Medical Corp. · Nov 1986
ADDITIONAL TARGET THERAPEUTICS GUIDE WIRES
K862983 · Target Therapeutics · Sep 1986
ACS HI-TORQUE FLEX-T GUIDE WIRE
K862360 · Advanced Cardiovascular Systems, Inc. · Sep 1986