The following data is part of a premarket notification filed by Sorin Group Deutschland Gmbh with the FDA for Sorin C5 System; 85/c5 Mast Roller Pump System 150(1x Rp 150 And Control Panel With Connecting Cables); S5/c5 Mast Rolle.
| Device ID | K103762 |
| 510k Number | K103762 |
| Device Name: | SORIN C5 SYSTEM; 85/C5 MAST ROLLER PUMP SYSTEM 150(1X RP 150 AND CONTROL PANEL WITH CONNECTING CABLES); S5/C5 MAST ROLLE |
| Classification | Console, Heart-lung Machine, Cardiopulmonary Bypass |
| Applicant | SORIN GROUP DEUTSCHLAND GMBH 49 PLAIN STREET North Attleboro, MA 02760 |
| Contact | Rosina Robinson, Rn, Med, Rac |
| Correspondent | Rosina Robinson, Rn, Med, Rac SORIN GROUP DEUTSCHLAND GMBH 49 PLAIN STREET North Attleboro, MA 02760 |
| Product Code | DTQ |
| CFR Regulation Number | 870.4220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-12-23 |
| Decision Date | 2011-01-20 |
| Summary: | summary |