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FDA 510(k)

HeartFlow FFRct Analysis

K-Number: K190925 · 2019-08-15

ApplicantHeartFlow, Inc.
Decision Date2019-08-15
Product CodePJA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HeartFlow FFRct Analysis is a medical device manufactured by HeartFlow, Inc.. It received FDA 510(k) clearance on 2019-08-15 under approval number K190925. 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 HeartFlow FFRct Analysis?

HeartFlow FFRct Analysis is a medical device that received FDA 510(k) clearance on 2019-08-15. It is manufactured by HeartFlow, Inc.. The 510(k) number is K190925.

When was HeartFlow FFRct Analysis approved by the FDA?

HeartFlow FFRct Analysis received FDA 510(k) clearance on 2019-08-15, under approval number K190925.

What company makes HeartFlow FFRct Analysis?

HeartFlow FFRct Analysis is manufactured by HeartFlow, Inc..

What is the FDA product code for HeartFlow FFRct Analysis?

The FDA product code for HeartFlow FFRct Analysis is PJA.

Other Devices by HeartFlow, Inc.

K161772FFRct K152733FFRct K182035FFRct K203329HeartFlow Analysis K213857HeartFlow Analysis K250902HeartFlow Analysis

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Related Devices (Code: PJA)

K161772FFRctHeartFlow, Inc. K152733FFRctHeartFlow, Inc. K182035FFRctHeartFlow, 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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