The following data is part of a premarket notification filed by Cobe Cardiovascular, Inc. with the FDA for Heat Exchanger Modification For Duo And Optima.
| Device ID | K944267 |
| 510k Number | K944267 |
| Device Name: | HEAT EXCHANGER MODIFICATION FOR DUO AND OPTIMA |
| Classification | Heat-exchanger, 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 | DTR |
| CFR Regulation Number | 870.4240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-01 |
| Decision Date | 1995-04-28 |