The following data is part of a premarket notification filed by Terumo Cardiovascular Systems Corp. with the FDA for Advanced Perfusion System 1 (aps1) Tube Clamp Assembly, Roller Pump 6 Inch Classic Color,.
| Device ID | K112587 |
| 510k Number | K112587 |
| Device Name: | ADVANCED PERFUSION SYSTEM 1 (APS1) TUBE CLAMP ASSEMBLY, ROLLER PUMP 6 INCH CLASSIC COLOR, |
| Classification | Pump, Blood, Cardiopulmonary Bypass, Roller Type |
| Applicant | TERUMO CARDIOVASCULAR SYSTEMS CORP. 6200 JACKSON RD. Ann Arbor, MI 48103 |
| Contact | Rebecca Andersen |
| Correspondent | Rebecca Andersen TERUMO CARDIOVASCULAR SYSTEMS CORP. 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 | 2011-09-06 |
| Decision Date | 2011-12-19 |
| Summary: | summary |