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FDA 510(k)

FFRct

K-Number: K161772 · 2016-08-24

ApplicantHeartFlow, Inc.
Decision Date2016-08-24
Product CodePJA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FFRct is a medical device manufactured by HeartFlow, Inc.. It received FDA 510(k) clearance on 2016-08-24 under approval number K161772. The device is classified under product code PJA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FFRct?

FFRct is a medical device that received FDA 510(k) clearance on 2016-08-24. It is manufactured by HeartFlow, Inc.. The 510(k) number is K161772.

When was FFRct approved by the FDA?

FFRct received FDA 510(k) clearance on 2016-08-24, under approval number K161772.

What company makes FFRct?

FFRct is manufactured by HeartFlow, Inc..

What is the FDA product code for FFRct?

The FDA product code for FFRct is PJA.

Other Devices by HeartFlow, Inc.

K152733FFRct K182035FFRct K190925HeartFlow FFRct Analysis K203329HeartFlow Analysis K213857HeartFlow Analysis K250902HeartFlow Analysis

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Related Devices (Code: PJA)

K152733FFRctHeartFlow, Inc. K182035FFRctHeartFlow, Inc. K190925HeartFlow FFRct AnalysisHeartFlow, Inc. K203329HeartFlow AnalysisHeartFlow, Inc. K213857HeartFlow AnalysisHeartFlow, Inc. K213657DEEPVESSEL FFRKeyamed Na, Inc.

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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