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 | K153376 |
| 510k Number | K153376 |
| 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 | Bryan Hann |
| Correspondent | Bryan Hann Terumo Cardiovascular Systems Corporation 6200 Jackson Road Ann Arbor, MI 48103 |
| Product Code | DTQ |
| CFR Regulation Number | 870.4220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-23 |
| Decision Date | 2015-12-16 |
| Summary: | summary |