The following data is part of a premarket notification filed by Cathworks Ltd with the FDA for Ffrangio System.
| Device ID | K182149 |
| 510k Number | K182149 |
| Device Name: | FFRangio System |
| Classification | Angiographic Coronary Vascular Physiologic Simulation Software |
| Applicant | CathWorks Ltd 3 Rapaport Street Kfar-saba, IL 4465141 |
| Contact | Miriam Ivenshitz |
| Correspondent | Sheila Hemeon-heyer Heyer Regulatory Solutions LLC 125 Cherry Lane Amherst, MA 01002 |
| Product Code | QEK |
| CFR Regulation Number | 870.1415 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-08 |
| Decision Date | 2018-12-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 17290017855025 | K182149 | 000 |