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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 a medical device manufactured by Boston Scientific Corporation. It received FDA 510(k) clearance on 2017-03-24 under approval 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. It is manufactured by Boston Scientific Corporation. The 510(k) number is K170204.

When was FFR Link, FFR Signal Processing Module approved by the FDA?

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

What company makes FFR Link, FFR Signal Processing Module?

FFR Link, FFR Signal Processing Module is manufactured by Boston Scientific Corporation.

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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Related PubMed Literature

PMID: 42056377 Signal detection of adverse events in medical devices using natural language processing: a case study in pelvic mesh. Scientific reports (2026)

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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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