Cleared Traditional

K914531 - STAINLESS STEEL GEN PUR INTERVENTIONAL ...

K914531 is an FDA 510(k) clearance for STAINLESS STEEL GEN PUR INTERVENTIONAL ..., 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 139-day FDA review.

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

FDA 510(k) Submission Details - K914531

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
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 520
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K914531.
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K914986 · E-Z-Em, Inc. · May 1992
DESERET GUIDEWIRE INTRODUCER
K915496 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1992
GUIDER DASHER
K915115 · Target Therapeutics · Feb 1992
GUIDER, DASHER
K914030 · Target Therapeutics · Feb 1992