Cleared Special

K042744 - OPTIV ANTAGE DH POWER INJECTION SYSTEM

K042744 is an FDA 510(k) clearance for OPTIV ANTAGE DH POWER INJECTION SYSTEM, manufactured by Mallinckrodt Inc., Liebel-Flarsheim Business. The device is a Class 2 Cardiovascular device with product code DXT cleared through the Special 510(k) pathway after a 57-day FDA review.

K042744 · Mallinckrodt Inc., Liebel-Flarsheim Business · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2004
Decision
57d
Days
Class 2
Risk

K042744 is an FDA 510(k) clearance for the OPTIV ANTAGE DH POWER INJECTION SYSTEM. Classified as Injector And Syringe, Angiographic (product code DXT), Class II - Special Controls.

Submitted by Mallinckrodt Inc., Liebel-Flarsheim Business (Cincinnati, US). The FDA issued a Cleared decision on November 30, 2004 after a review of 57 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. 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. Low regulatory complexity profile. 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

FDA 510(k) Submission Details - K042744

510(k) Number K042744 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 2004
Decision Date November 30, 2004
Days to Decision 57 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
68d faster than avg
Panel avg: 125d · This submission: 57d
Pathway characteristics
Modification to existing cleared device.

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 129
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