The following data is part of a premarket notification filed by Cobe Cardiovascular, Inc. with the FDA for New Cobe Cardioplegia System.
| Device ID | K920312 |
| 510k Number | K920312 |
| Device Name: | NEW COBE CARDIOPLEGIA SYSTEM |
| Classification | Reservoir, Blood, Cardiopulmonary Bypass |
| Applicant | COBE CARDIOVASCULAR, INC. 14401 WEST 65TH WAY Arvada, CO 80004 |
| Contact | Mary L Armstrong |
| Correspondent | Mary L Armstrong 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 | 1992-01-23 |
| Decision Date | 1992-10-01 |