The following data is part of a premarket notification filed by Bio-vascular, Inc. with the FDA for Cardio-cool.
| Device ID | K860523 |
| 510k Number | K860523 |
| Device Name: | CARDIO-COOL |
| Classification | Heat-exchanger, Cardiopulmonary Bypass |
| Applicant | BIO-VASCULAR, INC. 2670 PATTON RD. Saint Paul, MN 55113 |
| Contact | Ann M Riley |
| Correspondent | Ann M Riley BIO-VASCULAR, INC. 2670 PATTON RD. Saint Paul, MN 55113 |
| Product Code | DTR |
| CFR Regulation Number | 870.4240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-02-12 |
| Decision Date | 1986-04-29 |