The following data is part of a premarket notification filed by Cobe Cardiovascular, Inc. with the FDA for Smarxt Bmr 1900 Closed Venous Reservoir Bag.
| Device ID | K050111 |
| 510k Number | K050111 |
| Device Name: | SMARXT BMR 1900 CLOSED VENOUS RESERVOIR BAG |
| Classification | Reservoir, Blood, Cardiopulmonary Bypass |
| Applicant | COBE CARDIOVASCULAR, INC. 14401 WEST 65TH WAY Arvada, CO 80004 -3599 |
| Contact | Edward E Newton |
| Correspondent | Edward E Newton COBE CARDIOVASCULAR, INC. 14401 WEST 65TH WAY Arvada, CO 80004 -3599 |
| Product Code | DTN |
| CFR Regulation Number | 870.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-01-18 |
| Decision Date | 2005-03-08 |
| Summary: | summary |