Cleared Traditional

STAINLESS STEEL GEN PUR INTERVENTIONAL GUIDE WIRES (K914531) - FDA 510(k) Clearance

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

K914531 · Arrow Intl., Inc. · Cardiovascular device
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Feb 1992
Decision
139d
Days
Class 2
Risk

K914531 is an FDA 510(k) clearance for the STAINLESS STEEL GEN PUR INTERVENTIONAL GUIDE WIRES. 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 February 27, 1992 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 Arrow Intl., Inc. devices

Submission Details

510(k) Number K914531 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 1991
Decision Date February 27, 1992
Days to Decision 139 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
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 252
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K914531.
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K915496 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1992
CORDIS CINCH(R) STEERABLE GUIDEWIRE EXT W/SLX COAT
K914863 · Cordis Corp. · Dec 1991
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K913074 · Terumo Medical Corp. · Nov 1991