FFRangio
FDA 510(k) K192442 · Cathworks, Ltd.
510(k) numberK192442
Submission
- Device name
- FFRangio
- Applicant
- Cathworks, Ltd.
Kfar-Saba, IL - Received
- September 6, 2019
- Decision date
- December 9, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QEK – Angiographic Coronary Vascular Physiologic Simulation Software
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1415
- Specialty
- Cardiovascular
An angiographic coronary vascular physiologic simulation software device is intended to aid in the identification of functionally significant cardiovascular disease.
Other 510(k)s with product code QEK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K182149 | FFRangio SystemQEK · Traditional | Cathworks, Ltd. | 12/19/2018SE |
More from Cathworks, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K182149 | FFRangio SystemQEK · Traditional | 12/19/2018SE |
Questions and answers
When was FFRangio cleared by the FDA?
FFRangio (K192442) received a 510(k) decision of Substantially Equivalent on December 9, 2019, 94 days after the submission was received.
What is the product code of K192442?
The FDA product code is QEK – Angiographic Coronary Vascular Physiologic Simulation Software, a Class II (moderate risk) device regulated under 21 CFR 870.1415.