The following data is part of a premarket notification filed by Cobe Cardiovascular, Inc. with the FDA for Cobe Hvr 4000 Filtered Hardshell Venous Reservoir.
| Device ID | K984456 |
| 510k Number | K984456 |
| Device Name: | COBE HVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR |
| Classification | Reservoir, Blood, 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 | DTN |
| CFR Regulation Number | 870.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-12-15 |
| Decision Date | 1999-01-11 |
| Summary: | summary |