The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Intersept 1375 Venous Reservoir.
| Device ID | K903632 |
| 510k Number | K903632 |
| Device Name: | INTERSEPT 1375 VENOUS RESERVOIR |
| Classification | Reservoir, Blood, Cardiopulmonary Bypass |
| Applicant | MEDTRONIC VASCULAR 4633 E. LA PALMA AVE. Anaheim, CA 92807 |
| Contact | Norma L Lowe |
| Correspondent | Norma L Lowe MEDTRONIC VASCULAR 4633 E. LA PALMA AVE. Anaheim, CA 92807 |
| Product Code | DTN |
| CFR Regulation Number | 870.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-10 |
| Decision Date | 1990-12-17 |