The following data is part of a premarket notification filed by Terumo Cardiovascular Systems Corporation with the FDA for Advanced Perfusion System 1.
Device ID | K151349 |
510k Number | K151349 |
Device Name: | Advanced Perfusion System 1 |
Classification | Console, Heart-lung Machine, Cardiopulmonary Bypass |
Applicant | Terumo Cardiovascular Systems Corporation 6200 Jackson Road Ann Arbor, MI 48103 |
Contact | John Chesney |
Correspondent | John Chesney Terumo Cardiovascular Systems Corporation 6200 Jackson Road Ann Arbor, MI 48103 |
Product Code | DTQ |
CFR Regulation Number | 870.4220 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-05-20 |
Decision Date | 2015-08-27 |
Summary: | summary |