The following data is part of a premarket notification filed by Vascutek Ltd. with the FDA for Vascutek Gelweave Siena Collared Anteflo And Plexus With Radiopaque Markers.
| Device ID | K060142 |
| 510k Number | K060142 |
| Device Name: | VASCUTEK GELWEAVE SIENA COLLARED ANTEFLO AND PLEXUS WITH RADIOPAQUE MARKERS |
| Classification | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter |
| Applicant | VASCUTEK LTD. NEWMAINS AVE. INCHINNAN INDUSTRIAL ESTATE Renfrewshire, Scotland, GB Pa4 9rr |
| Contact | Karen Kelso |
| Correspondent | Karen Kelso VASCUTEK LTD. NEWMAINS AVE. INCHINNAN INDUSTRIAL ESTATE Renfrewshire, Scotland, GB Pa4 9rr |
| Product Code | DSY |
| CFR Regulation Number | 870.3450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-01-19 |
| Decision Date | 2006-02-07 |