The following data is part of a premarket notification filed by Vascutek Ltd. with the FDA for Temporary Limb Salvage Shunt.
| Device ID | K070323 |
| 510k Number | K070323 |
| Device Name: | TEMPORARY LIMB SALVAGE SHUNT |
| Classification | Clamp, Vascular |
| 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 | DXC |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-02-02 |
| Decision Date | 2007-02-15 |
| Summary: | summary |