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510(k) K251783

Inspire HCR and HCR DUAL cardiotomy reservoirs by Sorin Group Italia S.R.L. — Product Code DTN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 2025
Date Received
June 11, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Reservoir, Blood, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4400
Review Panel
CV
Submission Type

Other clearances by Sorin Group Italia S.R.L.

  • K253671 — Dual Stage Venous Cannulae (January 30, 2026)
  • 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)
  • K240584 — XTRA Autotransfusion System (with XTRA Bowl sets) (April 29, 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 DTN

  • K241206 — Quantum Perfusion Hybrid System (July 18, 2024)
  • K241053 — MVR™ Venous Reservoir Bag 800 mL; MVR™ Venous Reservoir Bag 1600 mL; MVR™ Venous (May 15, 2024)
  • K223361 — BMR 1900 PHISIO (June 10, 2023)
  • K170583 — Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive Surface (March 17, 2017)
  • K161733 — INSPIRE SVR 1200, INSPIRE 6F C, INSPIRE 8F C (March 8, 2017)
  • K153143 — Capiox Advance Hardshell Reservoir (December 2, 2015)
  • K151110 — Intersept Filtered Cardiotomy Reservoir (May 27, 2015)
  • K141432 — NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVIOR, PEDIATRIC VENOUS HARDSHELL CARDI (July 7, 2014)
  • K141233 — AFFINITY PIXIE OXYGENATION SYSTEM WITH; CARMEDA BIOACTIVE SURFACE, BALANCE BIOSU (June 12, 2014)
  • K140321 — INITARY BETTER BLADDER-PEDIATRIC (April 17, 2014)