Cleared Special

OPTIVANTAGE DH INJECTOR SYSTEM WITH ENHANCED COMMUNICATION (K063503) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K063503 · Mallinckrodt Inc., Liebel-Flarsheim Business · Cardiovascular device
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Apr 2007
Decision
158d
Days
Class 2
Risk

K063503 is an FDA 510(k) clearance for the OPTIVANTAGE DH INJECTOR SYSTEM WITH ENHANCED COMMUNICATION. Classified as Injector, Contrast Medium, Automatic (product code IZQ), Class II - Special Controls.

Submitted by Mallinckrodt Inc., Liebel-Flarsheim Business (Cincinnati, US). The FDA issued a Cleared decision on April 27, 2007 after a review of 158 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Mallinckrodt Inc., Liebel-Flarsheim Business devices

Submission Details

510(k) Number K063503 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 2006
Decision Date April 27, 2007
Days to Decision 158 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d slower than avg
Panel avg: 125d · This submission: 158d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code IZQ Injector, Contrast Medium, Automatic
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 - IZQ Injector, Contrast Medium, Automatic

All 21
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