Cleared Traditional

K810675 - ARROW RADIAL ARTERY CATHETERIZATION SET

K810675 is an FDA 510(k) clearance for ARROW RADIAL ARTERY CATHETERIZATION SET, 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 15-day FDA review.

K810675 · Arrow Intl., Inc. · Cardiovascular device
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Mar 1981
Decision
15d
Days
Class 2
Risk

K810675 is an FDA 510(k) clearance for the ARROW RADIAL ARTERY CATHETERIZATION SET. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Arrow Intl., Inc. (Mchenry, US). The FDA issued a Cleared decision on March 27, 1981 after a review of 15 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Arrow Intl., Inc. devices

FDA 510(k) Submission Details - K810675

510(k) Number K810675 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 1981
Decision Date March 27, 1981
Days to Decision 15 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
110d faster than avg
Panel avg: 125d · This submission: 15d
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 521
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K810675.
STAINLESS STEEL GUIDE WIRE
K831839 · Quinton, Inc. · Jul 1983
GUIDE WIRE
K821190 · Advanced Cardiovascular Systems, Inc. · Aug 1982
CATHETER GUIDE WIRE
K820699 · Quest Medical, Inc. · Apr 1982
BENZALKONIUM-HEPARIN COATED GUIDEWIRES
K802473 · Medrad, Inc. · Nov 1980
PERVENOUS LEAD INTRODUCER SYSTEM
K791276 · Cordis Corp. · Jul 1979
MOVABLE CORE SAFETY GUIDE
K790258 · Cordis Corp. · Feb 1979