The following data is part of a premarket notification filed by Sorin Group Deutschland Gmbh with the FDA for Stockert Heater-cooler System 3t.
| Device ID | K052601 |
| 510k Number | K052601 |
| Device Name: | STOCKERT HEATER-COOLER SYSTEM 3T |
| Classification | Controller, Temperature, Cardiopulmonary Bypass |
| Applicant | SORIN GROUP DEUTSCHLAND GMBH 49 PLAIN STREET North Attleboro, MA 02760 |
| Contact | Rosina Robinson |
| Correspondent | Rosina Robinson SORIN GROUP DEUTSCHLAND GMBH 49 PLAIN STREET North Attleboro, MA 02760 |
| Product Code | DWC |
| CFR Regulation Number | 870.4250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-21 |
| Decision Date | 2006-06-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04033817901549 | K052601 | 000 |
| 04033817901112 | K052601 | 000 |
| 04033817900528 | K052601 | 000 |
| 04033817900511 | K052601 | 000 |