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510(k) K221722

Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US) by Haemonetics Corporation — Product Code CAC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 15, 2022
Date Received
June 14, 2022
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 by Haemonetics Corporation

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  • K183160 — TEG 6s Hemostasis System, TEG 6s Citrated: K, RT, FF Assay Cartridge (May 9, 2019)
  • K160502 — TEG 6s Hemostasis System (April 19, 2017)
  • K162423 — Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (January 3, 2017)
  • K160197 — Haemonetics Cell Saver Elite Autotransfusion System (May 24, 2016)

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)
  • K201305 — Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suc (September 3, 2021)
  • K210862 — Hemafuse System (July 29, 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)