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FDA 510(k)

FFR Link, FFR Signal Processing Module

K-Number: K170204 · 2017-03-24

ApplicantBoston Scientific Corporation
Decision Date2017-03-24
Product CodeDRG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FFR Link, FFR Signal Processing Module 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 2017-03-24 under 510(k) number K170204. The device is classified under product code DRG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FFR Link, FFR Signal Processing Module?

FFR Link, FFR Signal Processing Module is a medical device that received FDA 510(k) clearance on 2017-03-24. The listed applicant is Boston Scientific Corporation. The 510(k) number is K170204.

When did FFR Link, FFR Signal Processing Module receive FDA 510(k) clearance?

FFR Link, FFR Signal Processing Module received FDA 510(k) clearance on 2017-03-24, under 510(k) number K170204.

Who is the listed applicant for FFR Link, FFR Signal Processing Module?

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 FFR Link, FFR Signal Processing Module?

The FDA product code for FFR Link, FFR Signal Processing Module is DRG.

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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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