The following data is part of a premarket notification filed by Terumo Cardiovascular Systems Corporation with the FDA for Large (6) Roller Pump For Terumo Advanced Perfusion System 1; Large (6) Roller Pump For Terumo Advanced Perfusion Syst.
| Device ID | K131618 |
| 510k Number | K131618 |
| Device Name: | LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYSTEM 1; LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYST |
| Classification | Pump, Blood, Cardiopulmonary Bypass, Roller Type |
| Applicant | Terumo Cardiovascular Systems Corporation 6200 JACKSON RD. Ann Arbor, MI 48103 |
| Contact | John Chesney |
| Correspondent | John Chesney Terumo Cardiovascular Systems Corporation 6200 JACKSON RD. Ann Arbor, MI 48103 |
| Product Code | DWB |
| CFR Regulation Number | 870.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-03 |
| Decision Date | 2013-09-27 |
| Summary: | summary |