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FDA 510(k)

LumiCoil Platinum Fiducial Marker

K-Number: K173251 · 2017-12-19

Decision Date2017-12-19
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

LumiCoil Platinum Fiducial Marker is a medical device manufactured by Boston Scientific Corporation. It received FDA 510(k) clearance on 2017-12-19 under approval number K173251. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LumiCoil Platinum Fiducial Marker?

LumiCoil Platinum Fiducial Marker is a medical device that received FDA 510(k) clearance on 2017-12-19. It is manufactured by Boston Scientific Corporation. The 510(k) number is K173251.

When was LumiCoil Platinum Fiducial Marker approved by the FDA?

LumiCoil Platinum Fiducial Marker received FDA 510(k) clearance on 2017-12-19, under approval number K173251.

What company makes LumiCoil Platinum Fiducial Marker?

LumiCoil Platinum Fiducial Marker is manufactured by Boston Scientific Corporation.

What is the FDA product code for LumiCoil Platinum Fiducial Marker?

The FDA product code for LumiCoil Platinum Fiducial Marker is IYE.

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Official Source

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