The following data is part of a premarket notification filed by Vascutek Ltd. with the FDA for Vascutek Cobrahood Eptfe Vascular Grafts.
| Device ID | K091778 |
| 510k Number | K091778 |
| Device Name: | VASCUTEK COBRAHOOD EPTFE VASCULAR GRAFTS |
| Classification | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter |
| Applicant | VASCUTEK LTD. NEWMAINS AVE. INCHINNAN INDUSTRIAL ESTATE Renfrewshire,glasgow,scotland, GB Pa4 9rr |
| Contact | Karen Kelso |
| Correspondent | Karen Kelso VASCUTEK LTD. NEWMAINS AVE. INCHINNAN INDUSTRIAL ESTATE Renfrewshire,glasgow,scotland, GB Pa4 9rr |
| Product Code | DSY |
| CFR Regulation Number | 870.3450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-06-17 |
| Decision Date | 2009-08-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05037881008998 | K091778 | 000 |
| 05037881008837 | K091778 | 000 |
| 05037881008820 | K091778 | 000 |
| 05037881008813 | K091778 | 000 |
| 05037881008806 | K091778 | 000 |
| 05037881008790 | K091778 | 000 |
| 05037881008783 | K091778 | 000 |
| 05037881008776 | K091778 | 000 |
| 05037881008769 | K091778 | 000 |
| 05037881008752 | K091778 | 000 |
| 05037881008745 | K091778 | 000 |
| 05037881008738 | K091778 | 000 |
| 05037881008721 | K091778 | 000 |
| 05037881008714 | K091778 | 000 |
| 05037881008844 | K091778 | 000 |
| 05037881008851 | K091778 | 000 |
| 05037881008981 | K091778 | 000 |
| 05037881008974 | K091778 | 000 |
| 05037881008967 | K091778 | 000 |
| 05037881008950 | K091778 | 000 |
| 05037881008943 | K091778 | 000 |
| 05037881008936 | K091778 | 000 |
| 05037881008929 | K091778 | 000 |
| 05037881008912 | K091778 | 000 |
| 05037881008905 | K091778 | 000 |
| 05037881008899 | K091778 | 000 |
| 05037881008882 | K091778 | 000 |
| 05037881008875 | K091778 | 000 |
| 05037881008868 | K091778 | 000 |
| 05037881008707 | K091778 | 000 |