The following data is part of a premarket notification filed by Medtronic, Inc. with the FDA for Eopa 3d Arterial Cannula.
| Device ID | K150422 |
| 510k Number | K150422 |
| Device Name: | EOPA 3D Arterial Cannula |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | MEDTRONIC, INC. 7611 Northland Dr. Minneapolis, MN 55428 |
| Contact | Chelsea L Pioske |
| Correspondent | Chelsea L Pioske MEDTRONIC, INC. 7611 Northland Dr. Minneapolis, MN 55428 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-02-19 |
| Decision Date | 2015-03-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20763000135700 | K150422 | 000 |
| 20763000135694 | K150422 | 000 |
| 20763000135526 | K150422 | 000 |
| 20763000135502 | K150422 | 000 |
| 20643169486250 | K150422 | 000 |
| 20643169486243 | K150422 | 000 |