510(k) K241236
K241236 is an FDA 510(k) premarket notification submitted by Sorin Group Italia S.R.L. for the device "XTRA Collection sets; XTRA Sequestration set X". The FDA issued a decision of Substantially Equivalent on August 16, 2024. The device falls under product code CAC (Apparatus, Autotransfusion), a Class II device regulated under 21 CFR 868.5830. Sorin Group Italia S.R.L. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 16, 2024
- Date Received
- May 2, 2024
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Apparatus, Autotransfusion
- Device Class
- Class II
- Regulation Number
- 868.5830
- Review Panel
- CV
- Submission Type