Cleared Special

K063784 - DYE MANAGEMENT SYSTEM

K063784 is the FDA 510(k) clearance for DYE MANAGEMENT SYSTEM by Icu Medical, Inc.. It is a Class 2 Cardiovascular device (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)
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.

View all Icu Medical, Inc. devices

Submission Details

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.

Device Classification

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 291
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K063784.
INNERCHANGE MICRO-INTRODUCER CATHETER, MODELS 7900, 7901, 7902, 7903, 7904 AND 7905
K073585 · Vascular Solutions, Inc. · Apr 2008
GANDRAS INTRAVASCULAR CATHETER, MODELS 5580, 5581 AND 5582
K073200 · Vascular Solutions, Inc. · Feb 2008
MEERCI RETRIEVER, CONCENTRIC MICROCATHETER, MODELS 90050, 90060, 90065, 90066, 90070,90092, 90043, 90044
K072796 · Concentric Medical, Inc. · Dec 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
MODIFICATION TO ATLANTIS SR PRO 2 AND SR PRO CORONARY IMAGING CATHETERS, MODEL 39014 AND 38942
K063312 · Boston Scientific Corp · Nov 2006