510(k) K182149
K182149 is an FDA 510(k) premarket notification submitted by Cathworks, Ltd. for the device "FFRangio System". The FDA issued a decision of Substantially Equivalent on December 19, 2018. 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 at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 19, 2018
- Date Received
- August 8, 2018
- Clearance Type
- Traditional
- 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
An angiographic coronary vascular physiologic simulation software device is intended to aid in the identification of functionally significant cardiovascular disease.