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.
| Device ID | K100507 |
| 510k Number | K100507 |
| Device Name: | XRES BLOOD COLLECTION RESERVOIR |
| Classification | Reservoir, Blood, Cardiopulmonary Bypass |
| Applicant | SORIN GROUP ITALIA S.R.L PAREXEL CONSULTING 195 WEST STREET Waltham, MA 02451 |
| Contact | Barry Sall |
| Correspondent | Barry Sall SORIN GROUP ITALIA S.R.L PAREXEL CONSULTING 195 WEST STREET Waltham, MA 02451 |
| Product Code | DTN |
| CFR Regulation Number | 870.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-02-22 |
| Decision Date | 2010-03-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08033178110846 | K100507 | 000 |