The following data is part of a premarket notification filed by Vascular Flow Technologies Ltd with the FDA for Spiral Flow Peripheral Vascular Graft.
| Device ID | K150389 |
| 510k Number | K150389 |
| Device Name: | Spiral Flow Peripheral Vascular Graft |
| Classification | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter |
| Applicant | VASCULAR FLOW TECHNOLOGIES LTD Prospect Business Centre GEMINI CRESENT, Dundee, GB Dd2 1ty |
| Contact | Edwin Lindsay |
| Correspondent | Edwin Lindsay VASCULAR FLOW TECHNOLOGIES LTD Prospect Business Centre GEMINI CRESENT, 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 | 2015-02-18 |
| Decision Date | 2015-05-06 |
| Summary: | summary |