FDA.reportPublic FDA data

510(k) K231782

Device
FlowSaver Blood Return System (80-101)
Applicant
Inari Medical, Inc.
510(k) number
K231782
Product code
CAC
Decision
Substantially Equivalent (SESE)
Decision date
2023-07-14
Date received
2023-06-16
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
Kaitlyn Weinkauf
Address
6001 Oak Canyon Suite 100 Irvine CA US 92618 92618

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
K241236XTRA Collection sets; XTRA Sequestration set XSorin Group Italia S.R.L.2024-08-16
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K240584XTRA Autotransfusion System (with XTRA Bowl sets)Sorin Group Italia S.R.L.2024-04-29
K221483FlowSaver Blood Return SystemInari Medical, Inc.2023-02-17
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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