The following data is part of a premarket notification filed by Sorin Group Deutschland Gmbh with the FDA for Sorin Flextherm.
| Device ID | K140012 |
| 510k Number | K140012 |
| Device Name: | SORIN FLEXTHERM |
| Classification | Controller, Temperature, Cardiopulmonary Bypass |
| Applicant | SORIN GROUP DEUTSCHLAND GMBH 14401 W 65TH WAY Arvada, CO 80004 |
| Contact | Scott Light |
| Correspondent | Scott Light SORIN GROUP DEUTSCHLAND GMBH 14401 W 65TH WAY Arvada, CO 80004 |
| Product Code | DWC |
| CFR Regulation Number | 870.4250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-01-02 |
| Decision Date | 2014-01-31 |
| Summary: | summary |