Cleared Special

K233853 - LumiGuide Wire

Also marketed or referenced as:
LumiGuide Equipment R2.0 LumiGuide 3D Hub

K233853 is an FDA 510(k) clearance for LumiGuide Wire, manufactured by Philips Medical Systems Nederland B.V.. The device is a Class 2 Cardiovascular device with product code DQK cleared through the Special 510(k) pathway after a 100-day FDA review.

K233853 · Philips Medical Systems Nederland B.V. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2024
Decision
100d
Days
Class 2
Risk

K233853 is an FDA 510(k) clearance for the LumiGuide Wire. Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.

Submitted by Philips Medical Systems Nederland B.V. (Best, NL). The FDA issued a Cleared decision on March 14, 2024 after a review of 100 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1425 - 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 - K233853

510(k) Number K233853 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 2023
Decision Date March 14, 2024
Days to Decision 100 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
25d faster than avg
Panel avg: 125d · This submission: 100d
Pathway characteristics
Modification to existing cleared device.

DQK Device Classification - Class 2, Special Controls

Product Code DQK Computer, Diagnostic, Programmable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1425
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 - DQK Computer, Diagnostic, Programmable

All 437
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K233853 · LumiGuide Wire
Download PDF FDA Summary Philips Medical Syste…