The following data is part of a premarket notification filed by Cathworks Ltd with the FDA for Ffrangio.
Device ID | K192442 |
510k Number | K192442 |
Device Name: | FFRangio |
Classification | Coronary Vascular Physiologic Simulation Software |
Applicant | CathWorks Ltd 3 Rapaport Street Kfar-saba, IL 4465141 |
Contact | Asaf Azulay |
Correspondent | Sheila Hemeon-heyer Heyer Regulatory Solutions LLC 125 Cherry Lane Amherst, MA 01002 |
Product Code | PJA |
CFR Regulation Number | 870.1415 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-09-06 |
Decision Date | 2019-12-09 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() FFRANGIO 87106889 not registered Live/Pending |
CathWorks Ltd. 2016-07-18 |