The following data is part of a premarket notification filed by Medtronic Perfusion Systems with the FDA for Eopa 3d Arterial Cannula, Models 78220,78222,78320,783222.
| Device ID | K061254 |
| 510k Number | K061254 |
| Device Name: | EOPA 3D ARTERIAL CANNULA, MODELS 78220,78222,78320,783222 |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | MEDTRONIC PERFUSION SYSTEMS 7611 NORTHLAND DR. Minneapolis, MN 55038 |
| Contact | Ronald W Bennett |
| Correspondent | Ronald W Bennett MEDTRONIC PERFUSION SYSTEMS 7611 NORTHLAND DR. Minneapolis, MN 55038 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-05-04 |
| Decision Date | 2006-06-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994888693 | K061254 | 000 |
| 00763000192976 | K061254 | 000 |
| 00763000238483 | K061254 | 000 |
| 00763000238490 | K061254 | 000 |
| 20613994845256 | K061254 | 000 |
| 20613994845263 | K061254 | 000 |
| 20613994845270 | K061254 | 000 |
| 20613994845287 | K061254 | 000 |
| 00643169159235 | K061254 | 000 |
| 00643169561076 | K061254 | 000 |
| 00643169561090 | K061254 | 000 |
| 00643169696266 | K061254 | 000 |
| 00643169696440 | K061254 | 000 |
| 00643169696457 | K061254 | 000 |
| 00613994888662 | K061254 | 000 |
| 00613994888679 | K061254 | 000 |
| 00763000192969 | K061254 | 000 |