The following data is part of a premarket notification filed by Vascutek Ltd. with the FDA for Vascutek Cannula Graft, Model Cgs2008s.
| Device ID | K081560 |
| 510k Number | K081560 |
| Device Name: | VASCUTEK CANNULA GRAFT, MODEL CGS2008S |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| 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 | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-06-03 |
| Decision Date | 2009-02-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05037881009537 | K081560 | 000 |