Cleared Traditional

K781561 - ANGIOGRAPHIC GUIDE WIRE

K781561 is an FDA 510(k) clearance for ANGIOGRAPHIC GUIDE WIRE, manufactured by Wilson Medical Instruments Co.. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K781561 · Wilson Medical Instruments Co. · Cardiovascular device
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Nov 1978
Decision
56d
Days
Class 2
Risk

K781561 is an FDA 510(k) clearance for the ANGIOGRAPHIC GUIDE WIRE. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Wilson Medical Instruments Co. (Mchenry, US). The FDA issued a Cleared decision on November 7, 1978 after a review of 56 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 Wilson Medical Instruments Co. devices

FDA 510(k) Submission Details - K781561

510(k) Number K781561 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 1978
Decision Date November 07, 1978
Days to Decision 56 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 125d · This submission: 56d
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 715
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K781561.
VASCULAR CATHETER WIREGUIDES
K802260 · Stanco Medical, Inc. · Oct 1980
PERVENOUS LEAD INTRODUCER SYSTEM
K791276 · Cordis Corp. · Jul 1979
MOVABLE CORE SAFETY GUIDE
K790258 · Cordis Corp. · Feb 1979
VARIABLE STIFFNESS WIRE GUIDE
K781393 · Cook, Inc. · Oct 1978
SAFETY SPRING GUIDES, TEFLON COATED
K780438 · C.R. Bard, Inc. · Jun 1978
ELECATH PLASTIC JACKETED GUIDEWIRE
K780493 · Electro-Catheter Corp. · Apr 1978