Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

FlowSaver Blood Return System

K-Number: K221483 · 2023-02-17

ApplicantInari Medical, Inc.
Decision Date2023-02-17
Product CodeCAC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

FlowSaver Blood Return System is a medical device manufactured by Inari Medical, Inc.. It received FDA 510(k) clearance on 2023-02-17 under approval number K221483. The device is classified under product code CAC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FlowSaver Blood Return System?

FlowSaver Blood Return System is a medical device that received FDA 510(k) clearance on 2023-02-17. It is manufactured by Inari Medical, Inc.. The 510(k) number is K221483.

When was FlowSaver Blood Return System approved by the FDA?

FlowSaver Blood Return System received FDA 510(k) clearance on 2023-02-17, under approval number K221483.

What company makes FlowSaver Blood Return System?

FlowSaver Blood Return System is manufactured by Inari Medical, Inc..

What is the FDA product code for FlowSaver Blood Return System?

The FDA product code for FlowSaver Blood Return System is CAC.

Related Clinical Trials

NCT01143558 Searching for Persistence of Infection in Lyme Disease COMPLETED NCT06727942 Virtual Reality-Infused Treadmill Training on Aging-Related Outcomes RECRUITING NCT01143454 Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System RECRUITING NCT01174108 Allogeneic Hematopoietic Stem Cell Transplantation for Severe Aplastic Anemia and Other Bone Marrow Failure Syndromes Using G-CSF Mobilized CD34+ Selected Hematopoietic Precursor Cells Co-Infused With a Reduced Dose of Non-Mobilized Donor T-cells RECRUITING NCT07499128 Continuous Temperature Monitoring (CTM) for Cytokine Release Syndrome (CRS), an Immune-Related Adverse Event ENROLLING_BY_INVITATION NCT03331380 Technical Development of Cardiovascular Magnetic Resonance Imaging (CMR) Using a Low Specific Absorption Rate (SAR) Scanner System RECRUITING

Related PubMed Literature

PMID: 41336744 From laboratory to pre-market prototyping: lessons learned from a noninvasive blood glucose level measurement device. Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference (2025)

Other Devices by Inari Medical, Inc.

K163549ClotTriever Thrombectomy System K181325FlowTriever Retrieval/Aspiration System K180466FlowTriever Retrieval/Aspiration System K180329ClotTriever Thrombectomy System K203333Triever20 Curve Catheter K212632ClotTriever Thrombectomy System

View all 29 devices →

Related Devices (Code: CAC)

K160735CATSmartFresenius Kabi AG K160197Haemonetics Cell Saver Elite Autotransfusion SystemHaemonetics Corporation K162423Haemonetics Cell Saver Elite/Elite+ Autotransfusion SystemHaemonetics Corporation K180831CATSmartFresenius Kabi AG K181954autoLog IQ Autotransfusion SystemMedtronic Perfusion Systems K192368CATSmartFresenius Kabi AG

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑