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FDA 510(k)

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

K-Number: K252645 · 2025-10-24

ApplicantPhilips Medical Systems Nederland B.V.
Decision Date2025-10-24
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LumiGuide Equipment R2.1; LumiGuide Wire; LumiGuide 3D Hub is a medical device manufactured by Philips Medical Systems Nederland B.V.. It received FDA 510(k) clearance on 2025-10-24 under approval number K252645. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LumiGuide Equipment R2.1; LumiGuide Wire; LumiGuide 3D Hub?

LumiGuide Equipment R2.1; LumiGuide Wire; LumiGuide 3D Hub is a medical device that received FDA 510(k) clearance on 2025-10-24. It is manufactured by Philips Medical Systems Nederland B.V.. The 510(k) number is K252645.

When was LumiGuide Equipment R2.1; LumiGuide Wire; LumiGuide 3D Hub approved by the FDA?

LumiGuide Equipment R2.1; LumiGuide Wire; LumiGuide 3D Hub received FDA 510(k) clearance on 2025-10-24, under approval number K252645.

What company makes LumiGuide Equipment R2.1; LumiGuide Wire; LumiGuide 3D Hub?

LumiGuide Equipment R2.1; LumiGuide Wire; LumiGuide 3D Hub is manufactured by Philips Medical Systems Nederland B.V..

What is the FDA product code for LumiGuide Equipment R2.1; LumiGuide Wire; LumiGuide 3D Hub?

The FDA product code for LumiGuide Equipment R2.1; LumiGuide Wire; LumiGuide 3D Hub is DQK.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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