Submission Details
| 510(k) Number | K240584 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 01, 2024 |
| Decision Date | April 29, 2024 |
| Days to Decision | 59 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Special
XTRA Autotransfusion System (with XTRA Bowl sets)
Apr 2024
Decision
59d
Days
Class 2
Risk
About This 510(k) Submission
K240584 is an FDA 510(k) clearance for the XTRA Autotransfusion System (with XTRA Bowl sets), a Apparatus, Autotransfusion (Class II — Special Controls, product code CAC), submitted by Sorin Group Italia S.R.L. (Mirandola ( Modena), IT). The FDA issued a Cleared decision on April 29, 2024, 59 days after receiving the submission on March 1, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 868.5830.
Device Classification
| Product Code | CAC — Apparatus, Autotransfusion |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 868.5830 |
Manufacturer
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