Cleared Traditional

K822586 - TEFLON COATED GUIDE WIRES & CATHETER

K822586 is the FDA 510(k) clearance for TEFLON COATED GUIDE WIRES & CATHETER by Universal Medical Instrument Corp.. It is a Class 2 Cardiovascular device (product code DQX) cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K822586 · Universal Medical Instrument Corp. · Cardiovascular device
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Oct 1982
Decision
53d
Days
Class 2
Risk

K822586 is an FDA 510(k) clearance for the TEFLON COATED GUIDE WIRES & CATHETER. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Universal Medical Instrument Corp. (Mchenry, US). The FDA issued a Cleared decision on October 18, 1982 after a review of 53 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 Universal Medical Instrument Corp. devices

Submission Details

510(k) Number K822586 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 1982
Decision Date October 18, 1982
Days to Decision 53 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 125d · This submission: 53d
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 502
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K822586.
CARDIOVASCULAR SPRING GUIDE WIRE
K834223 · Mallinckrodt Critical Care · Feb 1984
OPEN END SPRING GUIDE
K832607 · C.R. Bard, Inc. · Dec 1983
STAINLESS STEEL GUIDE WIRE
K831839 · Quinton, Inc. · Jul 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