Vascular Flow Technologies Limited · Class II · Cleared Oct 20, 2025
| K-number | K252277 |
| Device name | Spiral Laminar Flow Vascular Arteriovenous Graft (AV0645) |
| Applicant | Vascular Flow Technologies Limited |
| Product code | DSY |
| Device class | Class II |
| Decision date | Oct 20, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 870.3450 |
The Spiral Laminar Flow Vascular Arteriovenous Graft is a straight tube vascular prosthesis made of expanded polytetrafluoroethylene (ePTFE) with a spiral flow inducer and indicator ring. It is intended for use as a subcutaneous arteriovenous conduit to provide vascular access during hemodialysis and must be implanted by trained physicians or surgeons in a hospital operating theater.
The device features an ePTFE tube with a unique spiral flow inducer (helical wall deformation) and a nonremovable external indicator ring made of ChronoFlex AL-80A polyurethane. Modifications compared to the predicate devices include a different supplier of the base ePTFE material and a different chemical structure of the polyurethane overmold material. The graft is 6 mm in diameter and 450 mm in length with a shaped hood to guide distal anastomosis.
ISO 7198:2016 for cardiovascular implants and vascular prostheses; ISO 10993-1:2018 for biocompatibility evaluation; ISO 11135:2014 for ethylene oxide sterilization validation. Testing included suture retention strength, tensile strength, water entry pressure, kink resistance, hemocompatibility, and transit/environmental conditioning.
View the full FDA submission: accessdata.fda.gov