The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Intersept Filtered Cardiotomy Reservoir.
| Device ID | K926226 |
| 510k Number | K926226 |
| Device Name: | INTERSEPT FILTERED CARDIOTOMY RESERVOIR |
| Classification | Oxygenator, 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 | DTZ |
| CFR Regulation Number | 870.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-12-10 |
| Decision Date | 1993-06-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20613994529088 | K926226 | 000 |
| 20643169767618 | K926226 | 000 |
| 20673978562777 | K926226 | 000 |
| 20673978537188 | K926226 | 000 |