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 |