The following data is part of a premarket notification filed by Medtronic Perfusion Systems with the FDA for Medtronic Resting Heart System, Model Aar1000 And 711.
| Device ID | K031700 |
| 510k Number | K031700 |
| Device Name: | MEDTRONIC RESTING HEART SYSTEM, MODEL AAR1000 AND 711 |
| Classification | Reservoir, Blood, Cardiopulmonary Bypass |
| Applicant | MEDTRONIC PERFUSION SYSTEMS 7611 NORTHLAND DR. Minneapolis, MN 55038 |
| Contact | Preeti Jain |
| Correspondent | Preeti Jain MEDTRONIC PERFUSION SYSTEMS 7611 NORTHLAND DR. Minneapolis, MN 55038 |
| Product Code | DTN |
| CFR Regulation Number | 870.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2003-06-02 |
| Decision Date | 2003-08-29 |
| Summary: | summary |