510(k) K201881
K201881 is an FDA 510(k) premarket notification submitted by Coroventis Research AB for the device "CoroFlow Cardiovascular System". The FDA issued a decision of Substantially Equivalent on Nov 13, 2020. The device falls under product code DQK (Computer, Diagnostic, Programmable), a Class II device regulated under 21 CFR 870.1425. Coroventis Research AB has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 13, 2020
- Date Received
- Jul 7, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Computer, Diagnostic, Programmable
- Device Class
- Class II
- Regulation Number
- 870.1425
- Review Panel
- CV
- Submission Type