Cleared Special

LumiGuide Wire; LumiGuide Equipment R2.0; LumiGuide 3D Hub

K233853 · Philips Medical Systems Nederland B.V. · Cardiovascular
Mar 2024
Decision
100d
Days
Class 2
Risk

About This 510(k) Submission

K233853 is an FDA 510(k) clearance for the LumiGuide Wire; LumiGuide Equipment R2.0; LumiGuide 3D Hub, a Computer, Diagnostic, Programmable (Class II — Special Controls, product code DQK), submitted by Philips Medical Systems Nederland B.V. (Best, NL). The FDA issued a Cleared decision on March 14, 2024, 100 days after receiving the submission on December 5, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1425.

Submission Details

510(k) Number K233853 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code DQK — Computer, Diagnostic, Programmable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1425

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