Cleared Traditional

K973494 - HI-TORQUE BALANCE GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE WITH HYDG

K973494 is an FDA 510(k) clearance for HI-TORQUE BALANCE GUIDE WIRE WITH HYDRO..., manufactured by Guidant Corp.. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K973494 · Guidant Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1997
Decision
88d
Days
Class 2
Risk

K973494 is an FDA 510(k) clearance for the HI-TORQUE BALANCE GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, ACS HI-TORQU.... Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Guidant Corp. (Santa Clara, US). The FDA issued a Cleared decision on December 12, 1997 after a review of 88 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 Guidant Corp. devices

FDA 510(k) Submission Details - K973494

510(k) Number K973494 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 1997
Decision Date December 12, 1997
Days to Decision 88 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
37d faster than avg
Panel avg: 125d · This submission: 88d
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 689
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K973494.
CORDIS HYDRONOL STEERABLE GUIDEWIRE
K973845 · Cordis Corp. · Jan 1998
RADIAL AND FEMORAL ARTERY CATHETER
K971086 · B.Braun Medical, Inc. · Dec 1997
TOMCAT GUIDE WIRE, EXTENDER WIRE, GUIDE WIRE EXTENSION TOOL
K973708 · Merit Medical Systems, Inc. · Dec 1997
IVT 0.014 PTFE-COATED TRACKWIRE
K971688 · Boston Scientific /International Technologies · Dec 1997
HUNTER 0.014 INCH SUPER SOFT / HUNTER O.014 INCH SOFT GUIDE WIRES W/THROMBORESISTANT PC COATING
K970938 · Biocompatibles Cardiovascular, Inc. · Nov 1997
THEROX INFUSION GUIDEWIRES
K971719 · Therox, Inc. · Nov 1997