The following data is part of a premarket notification filed by Vascular Flow Technologies Ltd with the FDA for Spiral Flow Vascular Arteriovenous Graft.
| Device ID | K141124 |
| 510k Number | K141124 |
| Device Name: | SPIRAL FLOW VASCULAR ARTERIOVENOUS GRAFT |
| Classification | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter |
| Applicant | VASCULAR FLOW TECHNOLOGIES LTD Prospect Business Centre Gemini Cresent, Dundee Technology Park Dundee, GB Dd2 1ty |
| Contact | Edwin Lindsay |
| Correspondent | Edwin Lindsay VASCULAR FLOW TECHNOLOGIES LTD Prospect Business Centre Gemini Cresent, Dundee Technology Park Dundee, GB Dd2 1ty |
| Product Code | DSY |
| CFR Regulation Number | 870.3450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-05-01 |
| Decision Date | 2014-05-30 |