The following data is part of a premarket notification filed by Cardio Metrics, Inc. with the FDA for Mediastinal Autotransfusion System.
| Device ID | K860775 |
| 510k Number | K860775 |
| Device Name: | MEDIASTINAL AUTOTRANSFUSION SYSTEM |
| Classification | Defoamer, Cardiopulmonary Bypass |
| Applicant | CARDIO METRICS, INC. 10415 LANDSBURY DR. Houston, TX 77099 |
| Contact | Mary K Noonen |
| Correspondent | Mary K Noonen CARDIO METRICS, INC. 10415 LANDSBURY DR. Houston, TX 77099 |
| Product Code | DTP |
| CFR Regulation Number | 870.4230 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-03-03 |
| Decision Date | 1986-05-28 |