Cleared Traditional

K924385 - NEW HYDROPHILIC COATING FOR WIRE GUIDES (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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
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.

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 762
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