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 Number: 3014894404
• FEI Number: 3014894404
• Name: HeartFlow, Inc.
• Owner & Operator: HeartFlow, Inc.
• Contact Address: 1400 Seaport Blvd., Building B ; Redwood City CA 94063 US
• Official Correspondent:
  • Windi A Hary
  • 1-650-2411250-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 4516 Seton Center Parkway, Suite 200 ; Austin, TX 78759 US
• Establishment Type:
  • Complaint File Establishment per 21 CFR 820.198
  • Manufacture Medical Device

• Registration Number: 3011276938
• FEI Number: 3011276938
• Name: HEARTFLOW, INC.
• Owner & Operator: HeartFlow, Inc.
• Contact Address: 1400 Seaport Blvd., Building B ; Redwood City CA 94063 US
• Official Correspondent:
  • Windi A Hary
  • 1-650-2411250-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 1400 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	Device	Date
PMN K213857 HeartFlow, Inc.	HeartFlow Analysis	2022-10-14
GUDID 00853341006053 HEARTFLOW, INC.	HeartFlow Analysis	2021-06-16
PMN K203329 HeartFlow, Inc.	HeartFlow Analysis	2021-01-08
GUDID 00853341006039 HEARTFLOW, INC.	HeartFlow Analysis	2020-04-16
PMN K190925 | PJA HeartFlow, Inc.	HeartFlow FFRCT Analysis	2019-09-26
PMN K190925 | PJA HEARTFLOW, INC.	HeartFlow FFRCT Analysis	2019-09-26
PMN K190925 HeartFlow, Inc.	HeartFlow FFRct Analysis	2019-08-15
GUDID 00853341006022 HEARTFLOW, INC.	FFRct	2019-03-04
PMN K182035 | PJA HeartFlow, Inc.	HeartFlow FFRct	2019-01-07
PMN K182035 | PJA HeartFlow, Inc.	HeartFlow Analysis	2019-01-07
PMN K182035 | PJA HEARTFLOW, INC.	HeartFlow FFRct	2019-01-07
PMN K182035 | PJA HEARTFLOW, INC.	HeartFlow Analysis	2019-01-07
PMN K182035 HeartFlow, Inc	FFRct	2018-12-06
GUDID 00853341006015 HEARTFLOW, INC.	FFRct	2018-07-06
GUDID 00853341006008 HEARTFLOW, INC.	FFRct	2018-07-06
PMN K161772 | PJA HeartFlow, Inc.	HeartFlow FFRct	2016-10-27
PMN K161772 | PJA HeartFlow, Inc.	HeartFlow Analysis	2016-10-27
PMN K161772 | PJA HEARTFLOW, INC.	HeartFlow FFRct	2016-10-27
PMN K161772 | PJA HEARTFLOW, INC.	HeartFlow Analysis	2016-10-27
PMN K161772 HEARTFLOW, INC.	FFRct	2016-08-24
PMN K152733 | PJA HEARTFLOW, INC.	HeartFlow Analysis	2016-04-20
PMN K152733 | PJA HEARTFLOW, INC.	FFRCT	2016-04-20
PMN K152733 HEARTFLOW, INC.	FFRct	2016-01-13

Related Finance Registrations

NCAGE Code	4U4M1	HEARTFLOW, INC.
NCAGE Code	6A7F2	HEARTFLOW, INC
CAGE Code	4U4M1	HEARTFLOW, INC.
CAGE Code	6A7F2	HEARTFLOW, INC
S.A.M. Registration	4U4M1 [804411283]	HEARTFLOW, INC.
DUNS	804411283	Heartflow, Inc.
DUNS	042908031	HEARTFLOW, INC
SEC	0001464521	Heartflow, Inc. of DELAWARE