Home / 510(k) Clearances / K160735

510(k) K160735

CATSmart by Fresenius Kabi AG — Product Code CAC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 16, 2016
Date Received
March 17, 2016
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 Fresenius Kabi AG

  • K251139 — KabiHelp® Uno; KabiHelp® Advance plus (January 9, 2026)
  • K221121 — Volumat Polyethylene I.V. Administration Set (June 16, 2023)
  • K220301 — Volumat Line (June 2, 2023)
  • K212445 — freeflex+ Transfer Adapter (June 1, 2022)
  • K210073 — Agilia VP Infusion System, Agilia VP MC WIFI Infusion Pump, Volumat Lines Admini (March 1, 2022)
  • K210074 — Agilia SP Infusion System, Agilia SP MC WIFI Infusion Pump, Agilia Link, Agilia (March 1, 2022)
  • K210075 — Vigilant Software Suite – Vigilant Master Med (March 1, 2022)
  • K210089 — CATSmart, Automated Blood Processing Autotransfusion System (February 11, 2021)
  • K200530 — AMICUS Separator System (September 11, 2020)
  • K192150 — AMICUS Separator System (November 13, 2019)

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)
  • K210862 — Hemafuse System (July 29, 2021)
  • K210176 — FlowSaver Blood Filter (July 22, 2021)
  • K210089 — CATSmart, Automated Blood Processing Autotransfusion System (February 11, 2021)