Cleared Traditional

K904582 - QUICKWIRE - HYDROPHILIC COATED GUIDEWIRE

K904582 is the FDA 510(k) clearance for QUICKWIRE - HYDROPHILIC COATED GUIDEWIRE by Meadox Surgimed, Inc.. It is a Class 2 Cardiovascular device (product code DQX) cleared through the Traditional 510(k) pathway after a 139-day FDA review.

K904582 · Meadox Surgimed, Inc. · Cardiovascular device
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Feb 1991
Decision
139d
Days
Class 2
Risk

K904582 is an FDA 510(k) clearance for the QUICKWIRE - HYDROPHILIC COATED GUIDEWIRE. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Meadox Surgimed, Inc. (Oakland, US). The FDA issued a Cleared decision on February 25, 1991 after a review of 139 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Meadox Surgimed, Inc. devices

Submission Details

510(k) Number K904582 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 09, 1990
Decision Date February 25, 1991
Days to Decision 139 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d slower than avg
Panel avg: 125d · This submission: 139d
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 K904582.
OPEN ENDED GUIDEWIRE
K912878 · Lake Region Mfg., Inc. · Sep 1991
.010 HI-TORQUE GUIDE WIRES WITH PRESHAPED TIP
K911460 · Advanced Cardiovascular Systems, Inc. · Jun 1991
CORDIS REFLEX STEERABLE GUIDEWIRE
K905423 · Cordis Corp. · Mar 1991
PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY GUIDEWIRE
K905548 · Mallinckrodt Medical · Feb 1991
TORQUE HANDLE DEVICE FOR GUIDEWIRE
K905639 · Lake Region Mfg., Inc. · Feb 1991
SILICONE COATED GUIDEWIRES
K905581 · Lake Region Mfg., Inc. · Feb 1991