Heartflow Inc

FDA Filings

This page includes the latest FDA filings for Heartflow Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3014894404
FEI Number3014894404
NameHeartFlow, Inc.
Owner & OperatorHeartFlow, Inc.
Contact Address1400 Seaport Blvd., Building B
Redwood City CA 94063 US
Official Correspondent
  • Windi A Hary
  • 1-650-2411250-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address4516 Seton Center Parkway, Suite 200
Austin, TX 78759 US
Establishment Type
  • Complaint File Establishment per 21 CFR 820.198
  • Manufacture Medical Device



Registration Number3011276938
FEI Number3011276938
NameHEARTFLOW, INC.
Owner & OperatorHeartFlow, Inc.
Contact Address1400 Seaport Blvd., Building B
Redwood City CA 94063 US
Official Correspondent
  • Windi A Hary
  • 1-650-2411250-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address1400 Seaport Blvd Bldg B
Redwood City, CA 94063 US
Establishment Type
  • Complaint File Establishment per 21 CFR 820.198
  • Manufacture Medical Device



FDA Filings

Device
Company
DeviceDate
HeartFlow, Inc.
HeartFlow Analysis2021-01-08
HEARTFLOW, INC.
HeartFlow Analysis 2020-04-16
HeartFlow, Inc.
HeartFlow FFRCT Analysis2019-09-26
HEARTFLOW, INC.
HeartFlow FFRCT Analysis2019-09-26
HeartFlow, Inc.
HeartFlow FFRct Analysis2019-08-15
HEARTFLOW, INC.
FFRct 2019-03-04
HeartFlow, Inc.
HeartFlow FFRct2019-01-07
HeartFlow, Inc.
HeartFlow Analysis2019-01-07
HEARTFLOW, INC.
HeartFlow FFRct2019-01-07
HEARTFLOW, INC.
HeartFlow Analysis2019-01-07
HeartFlow, Inc
FFRct2018-12-06
HEARTFLOW, INC.
FFRct 2018-07-06
HEARTFLOW, INC.
FFRct 2018-07-06
HeartFlow, Inc.
HeartFlow FFRct2016-10-27
HeartFlow, Inc.
HeartFlow Analysis2016-10-27
HEARTFLOW, INC.
HeartFlow FFRct2016-10-27
HEARTFLOW, INC.
HeartFlow Analysis2016-10-27
HEARTFLOW, INC.
FFRct2016-08-24
HEARTFLOW, INC.
HeartFlow Analysis2016-04-20
HEARTFLOW, INC.
FFRCT2016-04-20
HEARTFLOW, INC.
FFRct2016-01-13

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