The following data is part of a premarket notification filed by Sorin Group Italia S.r.l. with the FDA for Xres Blood Collection Reservoir Xres 120micrometer Blood Collection Reservoir.
| Device ID | K131103 |
| 510k Number | K131103 |
| Device Name: | XRES BLOOD COLLECTION RESERVOIR XRES 120MICROMETER BLOOD COLLECTION RESERVOIR |
| Classification | Reservoir, Blood, Cardiopulmonary Bypass |
| Applicant | SORIN GROUP ITALIA S.R.L. 14401 W. 65TH WAY Arvada, CO 80004 |
| Contact | Scott Light |
| Correspondent | Scott Light SORIN GROUP ITALIA S.R.L. 14401 W. 65TH WAY Arvada, CO 80004 |
| Product Code | DTN |
| CFR Regulation Number | 870.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-04-19 |
| Decision Date | 2013-06-06 |
| Summary: | summary |