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510(k) K210862

Hemafuse System by Sisu Global Health — Product Code CAC

K210862 is an FDA 510(k) premarket notification submitted by Sisu Global Health for the device "Hemafuse System". The FDA issued a decision of Substantially Equivalent on July 29, 2021. The device falls under product code CAC (Apparatus, Autotransfusion), a Class II device regulated under 21 CFR 868.5830.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 29, 2021
Date Received
March 23, 2021
Clearance Type
Traditional
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

Other clearances for product code CAC

  • K241236 — XTRA Collection sets; XTRA Sequestration set X (August 16, 2024)
  • K240426 — Aventus Clot Management System (May 14, 2024)
  • K240584 — XTRA Autotransfusion System (with XTRA Bowl sets) (April 29, 2024)
  • K231782 — FlowSaver Blood Return System (80-101) (July 14, 2023)
  • K221483 — FlowSaver Blood Return System (February 17, 2023)
  • K221722 — Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US) (November 15, 2022)
  • K201305 — Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suc (September 3, 2021)
  • K210176 — FlowSaver Blood Filter (July 22, 2021)
  • K210089 — CATSmart, Automated Blood Processing Autotransfusion System (February 11, 2021)
  • K193361 — ProCell Surgical Sponge-Blood Recovery Unit (June 1, 2020)

FDA data resources