The following data is part of a premarket notification filed by Heartflow, Inc. with the FDA for Ffrct.
Device ID | K161772 |
510k Number | K161772 |
Device Name: | FFRct |
Classification | Coronary Vascular Physiologic Simulation Software |
Applicant | HEARTFLOW, INC. 1400 SEAPORT BOULEVARD BUILDING B Redwood City, CA 94063 |
Contact | Windi Hary |
Correspondent | Windi Hary HEARTFLOW, INC. 1400 SEAPORT BOULEVARD BUILDING B Redwood City, CA 94063 |
Product Code | PJA |
CFR Regulation Number | 870.1415 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-06-28 |
Decision Date | 2016-08-24 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00853341006015 | K161772 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() FFRCT 90808627 not registered Live/Pending |
Elucid Bioimaging Inc. 2021-07-02 |
![]() FFRCT 85334348 not registered Dead/Abandoned |
Heartflow, Inc. 2011-05-31 |
![]() FFRCT 85284255 4641484 Dead/Cancelled |
Heartflow, Inc. 2011-04-01 |