The following data is part of a premarket notification filed by Medtronic Cardiac Surgery, Medtronic, Inc. with the FDA for Cardiotherm Blood Cardioplegia Systems.
| Device ID | K960755 |
| 510k Number | K960755 |
| Device Name: | CARDIOTHERM BLOOD CARDIOPLEGIA SYSTEMS |
| Classification | Wire, Guide, Catheter |
| Applicant | MEDTRONIC CARDIAC SURGERY, MEDTRONIC, INC. 4633 EAST LA PALMA AVE. Anaheim, CA 92807 |
| Contact | Debra Kridner |
| Correspondent | Debra Kridner MEDTRONIC CARDIAC SURGERY, MEDTRONIC, INC. 4633 EAST LA PALMA AVE. Anaheim, CA 92807 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-02-23 |
| Decision Date | 1996-05-23 |
| Summary: | summary |