510(k) K252277
K252277 is an FDA 510(k) premarket notification submitted by Vascular Flow Technologies Limited for the device "Spiral Laminar Flow Vascular Arteriovenous Graft (AV0645)". The FDA issued a decision of Substantially Equivalent on October 20, 2025. The device falls under product code DSY (Prosthesis, Vascular Graft, Of 6mm And Greater Diameter), a Class II device regulated under 21 CFR 870.3450.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 20, 2025
- Date Received
- July 22, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
- Device Class
- Class II
- Regulation Number
- 870.3450
- Review Panel
- CV
- Submission Type