The following data is part of a premarket notification filed by Medtronic, Inc with the FDA for Intersept Filtered Cardiotomy Reservoir.
| Device ID | K151110 |
| 510k Number | K151110 |
| Device Name: | Intersept Filtered Cardiotomy Reservoir |
| Classification | Reservoir, Blood, Cardiopulmonary Bypass |
| Applicant | Medtronic, Inc 7611 Northland Drive Minneapolis, MN 55428 |
| Contact | Chelsea L Pioske |
| Correspondent | Chelsea L Pioske 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 | No |
| Date Received | 2015-04-27 |
| Decision Date | 2015-05-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20643169767656 | K151110 | 000 |
| 00643169653313 | K151110 | 000 |