Cleared Traditional

THE COEUR INJECTOR ADAPTOR/PRESSURE JACKET, MODEL C859-6003 (K032920) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

Device Classification

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 45
Devices cleared under the same product code (DXT) and FDA review panel - the closest regulatory comparables to K032920.
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K973230 · Merit Medical Systems, Inc. · Nov 1997
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K910873 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1991