The following data is part of a premarket notification filed by Medtronic, Inc. with the FDA for Intersept Filtered Cardiotomy Reservoir With Cortiva Bioactive Surface.
| Device ID | K170583 |
| 510k Number | K170583 |
| Device Name: | Intersept Filtered Cardiotomy Reservoir With Cortiva BioActive Surface |
| Classification | Reservoir, Blood, Cardiopulmonary Bypass |
| Applicant | Medtronic, Inc. 7611 Northland Drive Minneapolis, MN 55428 |
| Contact | Gayatri Ghadge |
| Correspondent | Gayatri Ghadge Medtronic, Inc. 7611 Northland Drive Minneapolis, MN 55428 |
| Product Code | DTN |
| CFR Regulation Number | 870.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2017-02-28 |
| Decision Date | 2017-03-17 |
| Summary: | summary |