The following data is part of a premarket notification filed by Medtronic Perfusion Systems with the FDA for Bio-console, Model 560.
Device ID | K051303 |
510k Number | K051303 |
Device Name: | BIO-CONSOLE, MODEL 560 |
Classification | Control, Pump Speed, Cardiopulmonary Bypass |
Applicant | MEDTRONIC PERFUSION SYSTEMS 7611 NORTHLAND DR. N Minneapolis, MN 55428 |
Contact | Dawn M Stenstrom |
Correspondent | Dawn M Stenstrom MEDTRONIC PERFUSION SYSTEMS 7611 NORTHLAND DR. N Minneapolis, MN 55428 |
Product Code | DWA |
CFR Regulation Number | 870.4380 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-05-19 |
Decision Date | 2005-06-10 |
Summary: | summary |