The following data is part of a premarket notification filed by Sorin Group Deutschland Gmbh with the FDA for Sorin Connect.
| Device ID | K170460 |
| 510k Number | K170460 |
| Device Name: | Sorin Connect |
| Classification | Display, Cathode-ray Tube, Medical |
| Applicant | Sorin Group Deutschland GmbH Lindberghstrasse, 25 Munich, DE 80939 |
| Contact | Luigi Vecchi |
| Correspondent | Scott Light Sorin Group USA, Inc. 14401 W 65th Way Arvada, CO 80004 |
| Product Code | DXJ |
| CFR Regulation Number | 870.2450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-02-15 |
| Decision Date | 2017-06-08 |
| Summary: | summary |