The following data is part of a premarket notification filed by Sorin Group Italia S.r.l. with the FDA for Xtra Autotransfusion System.
| Device ID | K101586 |
| 510k Number | K101586 |
| Device Name: | XTRA AUTOTRANSFUSION SYSTEM |
| 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 | 2010-06-07 |
| Decision Date | 2010-10-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 38033178111851 | K101586 | 000 |
| 38033178110021 | K101586 | 000 |
| 38033178110038 | K101586 | 000 |
| 38033178110045 | K101586 | 000 |
| 38033178110052 | K101586 | 000 |
| 38033178110069 | K101586 | 000 |
| 38033178110076 | K101586 | 000 |
| 38033178110083 | K101586 | 000 |
| 38033178110410 | K101586 | 000 |
| 38033178110526 | K101586 | 000 |
| 38033178110533 | K101586 | 000 |
| 38033178110755 | K101586 | 000 |
| 38033178110762 | K101586 | 000 |
| 38033178110779 | K101586 | 000 |
| 38033178110786 | K101586 | 000 |
| 38033178110793 | K101586 | 000 |
| 38033178110809 | K101586 | 000 |
| 38033178110014 | K101586 | 000 |