FDA.reportPublic FDA data

510(k) K241236

Device
XTRA Collection sets; XTRA Sequestration set X
Applicant
Sorin Group Italia S.R.L.
510(k) number
K241236
Product code
CAC
Decision
Substantially Equivalent (SESE)
Decision date
2024-08-16
Date received
2024-05-02
Regulation
868.5830
Classification name
Apparatus, Autotransfusion
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Martina Carlini
Address
Via Statale 12 Nord, 86 Mirandola ( Modena) IT 41037 41037

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code CAC#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K240426Aventus Clot Management SystemInquis Medical2024-05-14
K240584XTRA Autotransfusion System (with XTRA Bowl sets)Sorin Group Italia S.R.L.2024-04-29
K231782FlowSaver Blood Return System (80-101)Inari Medical, Inc.2023-07-14
K221483FlowSaver Blood Return SystemInari Medical, Inc.2023-02-17
K221722Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US)Haemonetics Corporation2022-11-15
K201305Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suction Water Seal Chest Drain, Express Dry Seal Chest DrainAtrium Medical Corporation2021-09-03
K210862Hemafuse SystemSisu Global Health2021-07-29
K210176FlowSaver Blood FilterInari Medical2021-07-22
K210089CATSmart, Automated Blood Processing Autotransfusion SystemFresenius Kabi AG2021-02-11
K193361ProCell Surgical Sponge-Blood Recovery UnitProcell Surgical, Inc.2020-06-01
K192368CATSmartFresenius Kabi AG2019-09-27
K180831CATSmartFresenius Kabi AG2018-12-10
K181954autoLog IQ Autotransfusion SystemMedtronic Perfusion Systems2018-08-22
K162423Haemonetics Cell Saver Elite/Elite+ Autotransfusion SystemHaemonetics Corporation2017-01-03
K160735CATSmartFresenius Kabi AG2016-09-16