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510(k) K240584

XTRA Autotransfusion System (with XTRA Bowl sets) by Sorin Group Italia S.R.L. — Product Code CAC

K240584 is an FDA 510(k) premarket notification submitted by Sorin Group Italia S.R.L. for the device "XTRA Autotransfusion System (with XTRA Bowl sets)". The FDA issued a decision of Substantially Equivalent on April 29, 2024. The device falls under product code CAC (Apparatus, Autotransfusion), a Class II device regulated under 21 CFR 868.5830. Sorin Group Italia S.R.L. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 29, 2024
Date Received
March 1, 2024
Clearance Type
Special
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 Sorin Group Italia S.R.L.

  • K253671 — Dual Stage Venous Cannulae (January 30, 2026)
  • K251783 — Inspire HCR and HCR DUAL cardiotomy reservoirs (December 22, 2025)
  • K253616 — ProtekDilate Vascular Access Kit (December 19, 2025)
  • K250610 — Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310) (June 27, 2025)
  • K250150 — VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set); VANGU (May 30, 2025)
  • K243264 — DHF 0.2 Hemoconcentrator (DHF 02); DHF 0.6 Hemoconcentrator (DHF 06); SH 14 Hemo (April 25, 2025)
  • K242953 — KIDS Arterial Filters (December 20, 2024)
  • K242092 — MICRO Arterial Filters (November 18, 2024)
  • K241236 — XTRA Collection sets; XTRA Sequestration set X (August 16, 2024)
  • K240193 — R501 - R502 aortic root cannulae with and without vent line (R501-15: R501-20: R (February 22, 2024)

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)
  • 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)
  • K193361 — ProCell Surgical Sponge-Blood Recovery Unit (June 1, 2020)

FDA data resources