Submission Details
| 510(k) Number | K241236 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 02, 2024 |
| Decision Date | August 16, 2024 |
| Days to Decision | 106 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Special
XTRA Collection sets; XTRA Sequestration set X
Aug 2024
Decision
106d
Days
Class 2
Risk
About This 510(k) Submission
K241236 is an FDA 510(k) clearance for the XTRA Collection sets; XTRA Sequestration set X, 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 August 16, 2024, 106 days after receiving the submission on May 2, 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
Similar Devices — CAC Apparatus, Autotransfusion
All 194
K240426 · Inquis Medical
· May 2024
K240584 · Sorin Group Italia S.R.L.
· Apr 2024
K231782 · Inari Medical, Inc.
· Jul 2023
K221483 · Inari Medical, Inc.
· Feb 2023
K221722 · Haemonetics Corporation
· Nov 2022
K201305 · Atrium Medical Corporation
· Sep 2021
More from Sorin Group Italia S.R.L.
View all
K253671
· DWF · Jan 2026
K251783
· DTN · Dec 2025
K253616
· DRE · Dec 2025
K250610
· DWF · Jun 2025
K250150
· DTR · May 2025