Cleared Abbreviated

LumiGuide Equipment R2.1; LumiGuide Wire; LumiGuide 3D Hub

K252645 · Philips Medical Systems Nederland B.V. · Cardiovascular
Oct 2025
Decision
64d
Days
Class 2
Risk

About This 510(k) Submission

K252645 is an FDA 510(k) clearance for the LumiGuide Equipment R2.1; LumiGuide Wire; 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 October 24, 2025, 64 days after receiving the submission on August 21, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1425.

Submission Details

510(k) Number K252645 FDA.gov
FDA Decision Cleared SESE
Date Received August 21, 2025
Decision Date October 24, 2025
Days to Decision 64 days
Submission Type Abbreviated
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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