The following data is part of a premarket notification filed by Terumo Cardiovascular Systems Corp. with the FDA for Advanced Perfusion System 1.
| Device ID | K131041 |
| 510k Number | K131041 |
| Device Name: | ADVANCED PERFUSION SYSTEM 1 |
| Classification | Console, Heart-lung Machine, Cardiopulmonary Bypass |
| Applicant | TERUMO CARDIOVASCULAR SYSTEMS CORP. 6200 JACKSON RD. Ann Arbor, MI 48103 |
| Contact | Mark Bur |
| Correspondent | Mark Bur TERUMO CARDIOVASCULAR SYSTEMS CORP. 6200 JACKSON RD. 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 | 2013-04-15 |
| Decision Date | 2014-02-20 |
| Summary: | summary |