510(k) K192442
K192442 is an FDA 510(k) premarket notification submitted by Cathworks, Ltd. for the device "FFRangio". The FDA issued a decision of Substantially Equivalent on Dec 9, 2019. The device falls under product code QEK (Angiographic Coronary Vascular Physiologic Simulation Software), a Class II device regulated under 21 CFR 870.1415. Cathworks, Ltd. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 9, 2019
- Date Received
- Sep 6, 2019
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Angiographic Coronary Vascular Physiologic Simulation Software
- Device Class
- Class II
- Regulation Number
- 870.1415
- Review Panel
- CV
- Submission Type
- 510(k)
An angiographic coronary vascular physiologic simulation software device is intended to aid in the identification of functionally significant cardiovascular disease.