The following data is part of a premarket notification filed by Sorin Group Deutschland Gmbh with the FDA for Sorin C5 System Model 58-00-00.
| Device ID | K093882 |
| 510k Number | K093882 |
| Device Name: | SORIN C5 SYSTEM MODEL 58-00-00 |
| 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 | 2009-12-18 |
| Decision Date | 2010-01-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04033817901440 | K093882 | 000 |
| 04033817901433 | K093882 | 000 |
| 04033817901426 | K093882 | 000 |
| 04033817900924 | K093882 | 000 |