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 the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corporation. It received FDA 510(k) clearance on 2017-12-19 under 510(k) 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. The listed applicant is Boston Scientific Corporation. The 510(k) number is K173251.

When did LumiCoil Platinum Fiducial Marker receive FDA 510(k) clearance?

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

Who is the listed applicant for LumiCoil Platinum Fiducial Marker?

The FDA 510(k) record lists Boston Scientific Corporation as the applicant. This does not by itself establish the device manufacturer.

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

View on FDA Database →

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