FDA 510(k)

HeartFlow FFRct Analysis

K-Number: K190925 · 2019-08-15

Decision Date2019-08-15

Product CodePJA

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

HeartFlow FFRct Analysis is the device name listed in this FDA 510(k) record. The listed applicant is HeartFlow, Inc.. It received FDA 510(k) clearance on 2019-08-15 under 510(k) 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. The listed applicant is HeartFlow, Inc.. The 510(k) number is K190925.

When did HeartFlow FFRct Analysis receive FDA 510(k) clearance?

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

Who is the listed applicant for HeartFlow FFRct Analysis?

The FDA 510(k) record lists HeartFlow, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HeartFlow FFRct Analysis?

The FDA product code for HeartFlow FFRct Analysis is PJA.

Other records listing HeartFlow, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250902HeartFlow Analysis K213857HeartFlow Analysis K203329HeartFlow Analysis K182035FFRct K161772FFRct K152733FFRct

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Related Devices (Code: PJA)

K250902HeartFlow AnalysisHeartFlow, Inc.K213857HeartFlow AnalysisHeartFlow, Inc.K213657DEEPVESSEL FFRKeyamed Na, Inc.K203329HeartFlow AnalysisHeartFlow, Inc.K182035FFRctHeartFlow, Inc.K161772FFRctHeartFlow, Inc.

Official Source

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