The following data is part of a premarket notification filed by Medtronic Blood Systems, Inc. with the FDA for Intersept*crystalloid Cardioplegia Delivery System.
| Device ID | K883439 |
| 510k Number | K883439 |
| Device Name: | INTERSEPT*CRYSTALLOID CARDIOPLEGIA DELIVERY SYSTEM |
| Classification | Heat-exchanger, Cardiopulmonary Bypass |
| Applicant | MEDTRONIC BLOOD SYSTEMS, INC. 4633 E. LA PALMA AVE. Anaheim, CA 92807 |
| Contact | Dennie W Dyer |
| Correspondent | Dennie W Dyer MEDTRONIC BLOOD SYSTEMS, INC. 4633 E. LA PALMA AVE. Anaheim, CA 92807 |
| Product Code | DTR |
| CFR Regulation Number | 870.4240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-08-15 |
| Decision Date | 1988-10-13 |