510(k) K213838
K213838 is an FDA 510(k) premarket notification submitted by ArteryFlow Technology Co., Ltd. for the device "AneuGuide". The FDA issued a decision of Substantially Equivalent on June 1, 2022. The device falls under product code PZO (Software For Visualization Of Vascular Anatomy And Intravascular Devices), a Class II device regulated under 21 CFR 892.2050. ArteryFlow Technology Co., Ltd. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 1, 2022
- Date Received
- December 9, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Software For Visualization Of Vascular Anatomy And Intravascular Devices
- Device Class
- Class II
- Regulation Number
- 892.2050
- Review Panel
- CV
- Submission Type
Visualization and measurement of blood vessels and intravascular devices for preoperational planning.