Cleared Traditional

K904582 - QUICKWIRE - HYDROPHILIC COATED GUIDEWIRE

K904582 is an FDA 510(k) clearance for QUICKWIRE - HYDROPHILIC COATED GUIDEWIRE, manufactured by Meadox Surgimed, Inc.. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K904582

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
Combination Product No
PCCP Authorized No
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.

DQX Device Classification - Class 2, Special Controls

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 690
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K904582.
TORQUE DEVICE FOR A GUIDE WIRE
K910969 · Terumo Corp. · May 1991
ULTRA-SELECT PTCA GUIDEWIRE
K910280 · Microvena Corp. · Apr 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