Cleared Traditional

K982083 - ACS HI-TORQUE BALANCE HEAVYWEIGHT GUIDE...

K982083 is the FDA 510(k) clearance for ACS HI-TORQUE BALANCE HEAVYWEIGHT GUIDE... by Guidant Corp.. It is a Class 2 Cardiovascular device (product code DQX) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K982083 · Guidant Corp. · Cardiovascular device
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Sep 1998
Decision
88d
Days
Class 2
Risk

K982083 is an FDA 510(k) clearance for the ACS HI-TORQUE BALANCE HEAVYWEIGHT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING. 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 September 11, 1998 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

Submission Details

510(k) Number K982083 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 1998
Decision Date September 11, 1998
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.

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 K982083.
HI-TORQUE STEELCORE 18 GUIDE WIRE MODEL NUMBERS 1003280, 1003281, 1003282
K982876 · Guidant Corp. · Nov 1998
ACS HT BALANCE MIDDLEWEIGHT GUIDE WIRE
K983033 · Guidant Corp. · Nov 1998
BARD HYDROPHILLIC COATED GUIDE WIRE
K974713 · C.R. Bard, Inc. · Oct 1998
CORE AND COIL ASSEMBLY GUIDEWIRE
K971322 · Lake Region Mfg., Inc. · Jul 1998
ACS HI-TORQUE CROSS-IT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING PRODUCT FAMILY MODELS 1003211H,1003212HJ,1003213H,1
K981381 · Guidant Corp. · Jul 1998
LAKE REGION MANUFACTURING GUIDEWIRES
K981326 · Lake Region Mfg., Inc. · Jul 1998