The following data is part of a premarket notification filed by Cobe Cardiovascular, Inc. with the FDA for Cobe Revolution.
| Device ID | K011835 |
| 510k Number | K011835 |
| Device Name: | COBE REVOLUTION |
| Classification | Pump, Blood, Cardiopulmonary Bypass, Non-roller Type |
| 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 | KFM |
| CFR Regulation Number | 870.4360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-06-12 |
| Decision Date | 2002-02-12 |
| Summary: | summary |