FFRangio
Coronary Vascular Physiologic Simulation Software
CathWorks Ltd
The following data is part of a premarket notification filed by Cathworks Ltd with the FDA for Ffrangio.
Pre-market Notification Details
| 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 |
Trademark Results [FFRangio]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FFRANGIO 87106889 not registered Live/Pending |
CathWorks Ltd. 2016-07-18 |
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