The following data is part of a premarket notification filed by Vascutek Ltd. with the FDA for Triaxil (vp50k) Knitted Vascular Prosthesis.
| Device ID | K910865 |
| 510k Number | K910865 |
| Device Name: | TRIAXIL (VP50K) KNITTED VASCULAR PROSTHESIS |
| Classification | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter |
| Applicant | VASCUTEK LTD. NEWMAINS AVENUE INCHINNAN RENFREWSHIRE Pa49rr Scotland, GB |
| Contact | Roshan Maini |
| Correspondent | Roshan Maini VASCUTEK LTD. NEWMAINS AVENUE INCHINNAN RENFREWSHIRE Pa49rr Scotland, GB |
| Product Code | DSY |
| CFR Regulation Number | 870.3450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-01 |
| Decision Date | 1991-04-01 |