The following data is part of a premarket notification filed by Cobe Cardiovascular, Inc. with the FDA for Cobe Vvr 4000 Filtered Hardshell Venous Reservoir, Cobe Smarxt Vvr 4000 Filtered Hardshell Venous Reservoir.
| Device ID | K004046 |
| 510k Number | K004046 |
| Device Name: | COBE VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR, COBE SMARXT VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR |
| Classification | Defoamer, Cardiopulmonary Bypass |
| Applicant | COBE CARDIOVASCULAR, INC. 14401 WEST 65TH WAY Arvada, CO 80004 |
| Contact | Lynne Leonard |
| Correspondent | Lynne Leonard COBE CARDIOVASCULAR, INC. 14401 WEST 65TH WAY Arvada, CO 80004 |
| Product Code | DTP |
| CFR Regulation Number | 870.4230 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-12-29 |
| Decision Date | 2001-04-26 |