Cleared Traditional

K032920 - THE COEUR INJECTOR ADAPTOR/PRESSURE JACKET, MODEL C859-6003

K032920 is an FDA 510(k) clearance for THE COEUR INJECTOR ADAPTOR/PRESSURE JACKET, manufactured by Coeur Medical. The device is a Class 2 Cardiovascular device with product code DXT cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K032920 · Coeur Medical · Cardiovascular device
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Dec 2003
Decision
85d
Days
Class 2
Risk

K032920 is an FDA 510(k) clearance for the THE COEUR INJECTOR ADAPTOR/PRESSURE JACKET, MODEL C859-6003. Classified as Injector And Syringe, Angiographic (product code DXT), Class II - Special Controls.

Submitted by Coeur Medical (Washington, US). The FDA issued a Cleared decision on December 16, 2003 after a review of 85 days - a notably fast clearance 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: 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 Coeur Medical devices

FDA 510(k) Submission Details - K032920

510(k) Number K032920 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 2003
Decision Date December 16, 2003
Days to Decision 85 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
40d faster than avg
Panel avg: 125d · This submission: 85d
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 146
Devices cleared under the same product code (DXT) and FDA review panel - the closest regulatory comparables to K032920.
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MEDRAD SPECTRIS SOLARIS MR INJECTOR SYSTEM
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MEDRAD MANUAL SYRINGE LOADER
K031483 · Medrad, Inc. · Aug 2003
MEDRAD STELLANT CT INJECTOR SYSTEM
K023183 · Medrad, Inc. · Jan 2003