The following data is part of a premarket notification filed by Terumo Cardiovascular Systems Corporation with the FDA for Small (4) Roller Pump For The Terumo Advanced Perfusion System 1, Large (6) Roller Pump For The Terumo Advanced Perfusion System 1.
| Device ID | K162843 |
| 510k Number | K162843 |
| Device Name: | Small (4) Roller Pump For The Terumo Advanced Perfusion System 1, Large (6) Roller Pump For The Terumo Advanced Perfusion System 1 |
| Classification | Pump, Blood, Cardiopulmonary Bypass, Roller Type |
| 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 | DWB |
| CFR Regulation Number | 870.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-10-11 |
| Decision Date | 2016-11-17 |
| Summary: | summary |