Cleared Special

K063784 - DYE MANAGEMENT SYSTEM

K063784 is an FDA 510(k) clearance for DYE MANAGEMENT SYSTEM, manufactured by Icu Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DQO cleared through the Special 510(k) pathway after a 116-day FDA review.

K063784 · Icu Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2007
Decision
116d
Days
Class 2
Risk

K063784 is an FDA 510(k) clearance for the DYE MANAGEMENT SYSTEM. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Icu Medical, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on April 16, 2007 after a review of 116 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1200 - 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 - K063784

510(k) Number K063784 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 2006
Decision Date April 16, 2007
Days to Decision 116 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
9d faster than avg
Panel avg: 125d · This submission: 116d
Pathway characteristics
Modification to existing cleared device.

DQO Device Classification - Class 2, Special Controls

Product Code DQO Catheter, Intravascular, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1200
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 - DQO Catheter, Intravascular, Diagnostic

All 498
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K063784.
MICRUS COURIER ENZO MICROCATHETER 0.0190
K072526 · Micrus Endovascular Corporation · Oct 2007
DISPOSABLE HIGH PRESSURE INJECTION LINES WITH AND WITHOUT ROTATING ADAPTERS
K071196 · Coeur, Inc. · Sep 2007
MICRUS COURIER ENZO MICROCATHETER 0.017
K070456 · Micrus Endovascular Corporation · May 2007
IBI INQUIRY CLEARICE INTRACARDIAC ECHOCARDIOGRAPHY ULTRASOUND IMAGING CATHETER
K070011 · Irvine Biomedical,Inc.(Ibi) · Mar 2007
TWIN-PASS .023 DUAL ACCESS CATHETER, MODEL 5230
K062877 · Vascular Solutions, Inc. · Jan 2007
INNERCHANGE MICRO-INTRODUCER CATHETER, MODELS 7900 THROUGH 7905
K062627 · Vascular Solutions, Inc. · Jan 2007
K063784 · DYE MANAGEMENT SYSTEM
Download PDF FDA Summary Icu Medical, Inc.