The following data is part of a premarket notification filed by Medtronic Bio-medicus, Inc. with the FDA for Css-cardioplegia Safety System.
| Device ID | K973237 |
| 510k Number | K973237 |
| Device Name: | CSS-CARDIOPLEGIA SAFETY SYSTEM |
| Classification | Pump, Blood, Cardiopulmonary Bypass, Roller Type |
| Applicant | MEDTRONIC BIO-MEDICUS, INC. 9600 WEST 76TH ST. Eden Prairie, MN 55344 |
| Contact | Thomas K Johnson |
| Correspondent | Thomas K Johnson MEDTRONIC BIO-MEDICUS, INC. 9600 WEST 76TH ST. Eden Prairie, MN 55344 |
| Product Code | DWB |
| CFR Regulation Number | 870.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-08-28 |
| Decision Date | 1998-04-27 |
| Summary: | summary |