Cleared Traditional

K983033 - ACS HT BALANCE MIDDLEWEIGHT GUIDE WIRE

K983033 is the FDA 510(k) clearance for ACS HT BALANCE MIDDLEWEIGHT GUIDE WIRE by Guidant Corp.. It is a Class 2 Cardiovascular device (product code DQX) cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K983033 · Guidant Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1998
Decision
71d
Days
Class 2
Risk

K983033 is an FDA 510(k) clearance for the ACS HT BALANCE MIDDLEWEIGHT GUIDE WIRE. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Guidant Corp. (Temecula, US). The FDA issued a Cleared decision on November 10, 1998 after a review of 71 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

Submission Details

510(k) Number K983033 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 1998
Decision Date November 10, 1998
Days to Decision 71 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
54d faster than avg
Panel avg: 125d · This submission: 71d
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 K983033.
SCIMED INFORMER PRESSURE WIRE SYSTEM
K974241 · Scimed Life Systems, Inc. · Nov 1998
STRATEGY CORONARY WIRE GUIDE
K983771 · Cook, Inc. · Nov 1998
HI-TORQUE STEELCORE 18 GUIDE WIRE MODEL NUMBERS 1003280, 1003281, 1003282
K982876 · Guidant Corp. · Nov 1998
BARD HYDROPHILLIC COATED GUIDE WIRE
K974713 · C.R. Bard, Inc. · Oct 1998
ACS HI-TORQUE BALANCE HEAVYWEIGHT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING
K982083 · Guidant Corp. · Sep 1998
CORE AND COIL ASSEMBLY GUIDEWIRE
K971322 · Lake Region Mfg., Inc. · Jul 1998