Cleared Traditional

K831839 - STAINLESS STEEL GUIDE WIRE

K831839 is the FDA 510(k) clearance for STAINLESS STEEL GUIDE WIRE by Quinton, Inc.. It is a Class 2 Cardiovascular device (product code DQX) cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K831839 · Quinton, Inc. · Cardiovascular device
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Jul 1983
Decision
41d
Days
Class 2
Risk

K831839 is an FDA 510(k) clearance for the STAINLESS STEEL GUIDE WIRE. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Quinton, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 18, 1983 after a review of 41 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 Quinton, Inc. devices

Submission Details

510(k) Number K831839 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 1983
Decision Date July 18, 1983
Days to Decision 41 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
84d faster than avg
Panel avg: 125d · This submission: 41d
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 513
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K831839.
WIREGUIDE OR GUIDEWIRE
K843012 · Medi-Tech, Inc. · Nov 1984
CARDIOVASCULAR SPRING GUIDE WIRE
K834223 · Mallinckrodt Critical Care · Feb 1984
OPEN END SPRING GUIDE
K832607 · C.R. Bard, Inc. · Dec 1983
GUIDE WIRE
K821190 · Advanced Cardiovascular Systems, Inc. · Aug 1982
CATHETER GUIDE WIRE
K820699 · Quest Medical, Inc. · Apr 1982
ARROW RADIAL ARTERY CATHETERIZATION SET
K810675 · Arrow Intl., Inc. · Mar 1981