510(k) K222023
K222023 is an FDA 510(k) premarket notification submitted by Hexacath for the device "RayFlow". The FDA issued a decision of Substantially Equivalent on Apr 6, 2023. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 6, 2023
- Date Received
- Jul 11, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Percutaneous
- Device Class
- Class II
- Regulation Number
- 870.1250
- Review Panel
- CV
- Submission Type
- 510(k)