Cleared Special

K063503 - OPTIVANTAGE DH INJECTOR SYSTEM WITH ENHANCED COMMUNICATION

K063503 is an FDA 510(k) clearance for OPTIVANTAGE DH INJECTOR SYSTEM WITH ENH..., manufactured by Mallinckrodt Inc., Liebel-Flarsheim Business. The device is a Class 2 Cardiovascular device with product code IZQ cleared through the Special 510(k) pathway after a 158-day FDA review.

K063503 · Mallinckrodt Inc., Liebel-Flarsheim Business · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K063503

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
33d slower than avg
Panel avg: 125d · This submission: 158d
Pathway characteristics
Modification to existing cleared device.

IZQ Device Classification - Class 2, Special Controls

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 22
Devices cleared under the same product code (IZQ) and FDA review panel - the closest regulatory comparables to K063503.
CT Expres 3D Contrast Media Delivery System, Bottle Spike Type B, Day Set III HP, Patient Set
K151048 · Bracco Injeneering · Jan 2016
OptiOne Single-Head Contrast Delivery System with Pedestal
K152361 · Liebel-Flarsheim Company, LLC · Jan 2016
SONIC SHOT GX
K091734 · Nemoto Kyorindo Co., Ltd. · May 2010
EMPOWERMR INJECTOR SYSTEM, MODEL 9730
K062449 · E-Z-Em, Inc. · Apr 2007
MEDRAD STELLANT CT INJECTOR SYSTEM WITH XDS ACCESSORY
K063090 · Medrad, Inc. · Mar 2007
CT EXPRES III CONTRAST MEDIA DELIVERY SYSTEM
K062265 · Swiss Medical Care S.A. · Dec 2006
K063503 · OPTIVANTAGE DH INJECTOR SYSTEM WITH ENHANCED COMMUNICATION
Download PDF FDA Summary Mallinckrodt Inc., Li…