Cleared Traditional

K924385 - NEW HYDROPHILIC COATING FOR WIRE GUIDES

K924385 is an FDA 510(k) clearance for NEW HYDROPHILIC COATING FOR WIRE GUIDES, manufactured by Arrow Intl., Inc.. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 356-day FDA review.

K924385 · Arrow Intl., Inc. · Cardiovascular device
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Aug 1993
Decision
356d
Days
Class 2
Risk

K924385 is an FDA 510(k) clearance for the NEW HYDROPHILIC COATING FOR WIRE GUIDES. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Arrow Intl., Inc. (Reading, US). The FDA issued a Cleared decision on August 15, 1993 after a review of 356 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Arrow Intl., Inc. devices

FDA 510(k) Submission Details - K924385

510(k) Number K924385 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 1992
Decision Date August 15, 1993
Days to Decision 356 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
231d slower than avg
Panel avg: 125d · This submission: 356d
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 520
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K924385.
USCI MACH 10 GUIDE WIRE WITH PRO/PEL COATING
K933466 · C.R. Bard, Inc. · Oct 1993
B-D ARTERIAL BLOOD CONTAINMENT DEVICE
K925947 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1993
ARROW BLOOD CONTAINMENT DEVICE
K924558 · Arrow Intl., Inc. · Aug 1993
SCIMED(R) ENTRE(TM) II PTCA GUIDE WIRE & ACCESSORY
K931514 · Scimed Life Systems, Inc. · Jun 1993
TERUMO CORONARY GUIDE WIRE
K925852 · Terumo Medical Corp. · Jun 1993
DOC-TITE(TM) GUIDE WIRE EXTENSION
K931171 · Advanced Cardiovascular Systems, Inc. · Jun 1993