The following data is part of a premarket notification filed by Cobe Cardiovascular, Inc. with the FDA for Cobe Smarxt Hvr 4000 Surface Modified Hardshell Venous Reservoir, Filtered & Nonfiltered.
| Device ID | K993001 |
| 510k Number | K993001 |
| Device Name: | COBE SMARXT HVR 4000 SURFACE MODIFIED HARDSHELL VENOUS RESERVOIR, FILTERED & NONFILTERED |
| Classification | Reservoir, Blood, Cardiopulmonary Bypass |
| Applicant | COBE CARDIOVASCULAR, INC. 14401 WEST 65TH WAY Arvada, CO 80004 |
| Contact | Lynn Leonard |
| Correspondent | Lynn Leonard COBE CARDIOVASCULAR, INC. 14401 WEST 65TH WAY Arvada, CO 80004 |
| Product Code | DTN |
| CFR Regulation Number | 870.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-09-07 |
| Decision Date | 1999-12-03 |
| Summary: | summary |