Sorin Group Italia S.R.L. - FDA 510(k) Cleared Devices

Cleared Jan 30, 2026

Dual Stage Venous Cannulae

K253671 · DWF

Cardiovascular · 70d

Cleared Dec 22, 2025

Inspire HCR and HCR DUAL cardiotomy reservoirs

K251783 · DTN

Cardiovascular · 194d

Cleared Dec 19, 2025

ProtekDilate Vascular Access Kit

K253616 · DRE

Cardiovascular · 31d

Cleared Jun 27, 2025

Easyflow (103-200

K250610 · DWF

Cardiovascular · 119d

Cleared May 30, 2025

VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set)

K250150 · DTR

Cardiovascular · 129d

Cleared Dec 20, 2024

KIDS Arterial Filters

K242953 · DTM

Cardiovascular · 86d

Cleared Nov 18, 2024

MICRO Arterial Filters

K242092 · DTM

Cardiovascular · 124d

Cleared Aug 16, 2024

XTRA Collection sets

K241236 · CAC

Cardiovascular · 106d

Cleared Apr 29, 2024

XTRA Autotransfusion System (with XTRA Bowl sets)

K240584 · CAC

Cardiovascular · 59d

Cleared Feb 22, 2024

R501 - R502 aortic root cannulae with and without vent line (R501-15:...

K240193 · DWF

Cardiovascular · 29d

Cleared Nov 16, 2023

D100 KIDS

K231652 · DTZ

Cardiovascular · 163d

Cleared Jun 10, 2023

BMR 1900 PHISIO

K223361 · DTN

Cardiovascular · 219d