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 |