Cleared Traditional

K910594 - TRAC-WRIGHT SYSTEM

K910594 is an FDA 510(k) clearance for TRAC-WRIGHT SYSTEM, manufactured by Dow Corning Wright. The device is a Class 2 Cardiovascular device with product code DXT cleared through the Traditional 510(k) pathway after a 223-day FDA review.

K910594 · Dow Corning Wright · Cardiovascular device
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Sep 1991
Decision
223d
Days
Class 2
Risk

K910594 is an FDA 510(k) clearance for the TRAC-WRIGHT SYSTEM, MODEL TW2. Classified as Injector And Syringe, Angiographic (product code DXT), Class II - Special Controls.

Submitted by Dow Corning Wright (Arlington, US). The FDA issued a Cleared decision on September 23, 1991 after a review of 223 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1650 - 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 Dow Corning Wright devices

FDA 510(k) Submission Details - K910594

510(k) Number K910594 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 1991
Decision Date September 23, 1991
Days to Decision 223 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
98d slower than avg
Panel avg: 125d · This submission: 223d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXT Device Classification - Class 2, Special Controls

Product Code DXT Injector And Syringe, Angiographic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1650
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 - DXT Injector And Syringe, Angiographic

All 105
Devices cleared under the same product code (DXT) and FDA review panel - the closest regulatory comparables to K910594.
MEDRAD MCT, MCT PLUS INJECTOR/MEDRAD FRONT LOAD
K924116 · Medrad, Inc. · Jan 1993
MEDRAD MCT-PLUS INJECTOR
K913624 · Medrad, Inc. · Jul 1992
CT 8000 DIGITAL INJECTION SYSTEM
K912944 · Mallinckrodt Group, Inc. · Feb 1992
MEDRAD VARIBLE INFUSION INJECTOR
K905819 · Medrad, Inc. · Sep 1991
BD ANGIOGRAPHIC SYRINGE W/A ROTATING TIP
K910873 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1991
CLOSED SYSTEM FLUSH SET
K904994 · Argon Medical Corp. · Jan 1991