FFRangio System— 510(k) K182149
Substantially EquivalentCathworks, Ltd.
FDA 510(k) clearance K182149 for FFRangio System, Substantially Equivalent on 2018-12-19. Applicant: Cathworks, Ltd.. Device class: 2.
Clearance details
- Applicant
- Cathworks, Ltd.
- Product code
- Code QEK
- Device class
- Class 2
- Regulation
- 21 CFR 870.1415
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Kfar-Saba, IL
Recent devices under product code QEK
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