The following data is part of a premarket notification filed by Sorin Group Italia S.r.l. with the FDA for Xvac.
| Device ID | K110782 |
| 510k Number | K110782 |
| Device Name: | XVAC |
| Classification | Apparatus, Autotransfusion |
| Applicant | SORIN GROUP ITALIA S.R.L. 195 WEST STREET Waltham, MA 02451 |
| Contact | Barry Sall |
| Correspondent | Barry Sall SORIN GROUP ITALIA S.R.L. 195 WEST STREET Waltham, MA 02451 |
| Product Code | CAC |
| CFR Regulation Number | 868.5830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-03-21 |
| Decision Date | 2011-04-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04033817753070 | K110782 | 000 |