Medical Device Manufacturer · IT , Mirandola

Sorin Group Italia S.R.L.

61 submissions · 61 cleared · Since 1995
61
Total
61
Cleared
0
Denied

Sorin Group Italia S.R.L. — FDA 510(k) Submissions

Sorin Group Italia S.R.L. has submitted 61 FDA 510(k) premarket notifications since 1995, of which 61 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Oxygenator, Cardiopulmonary Bypass, Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass, Reservoir, Blood, Cardiopulmonary Bypass, Apparatus, Autotransfusion, Filter, Blood, Cardiopulmonary Bypass, Arterial Line . Use the specialty filter in the sidebar to narrow results.

61 devices
1–25 of 61
Dual Stage Venous Cannulae
K253671 · DWF Catheter, Cannula And... · Cardiovascular
Jan 2026 70d
Inspire HCR and HCR DUAL cardiotomy reservoirs
K251783 · DTN Reservoir, Blood,... · Cardiovascular
Dec 2025 194d
ProtekDilate Vascular Access Kit
K253616 · DRE Dilator, Vessel, For... · Cardiovascular
Dec 2025 31d
Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310)
K250610 · DWF Catheter, Cannula And... · Cardiovascular
Jun 2025 119d
VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set with shunt); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood Cardioplegia Set Mini)
K250150 · DTR Heat-exchanger,... · Cardiovascular
May 2025 129d
DHF 0.2 Hemoconcentrator (DHF 02); DHF 0.6 Hemoconcentrator (DHF 06); SH 14 Hemoconcentrator (SH 14)
K243264 · KDI Dialyzer, High... · Gastroenterology & Urology
Apr 2025 192d
KIDS Arterial Filters
K242953 · DTM Filter, Blood,... · Cardiovascular
Dec 2024 86d
MICRO Arterial Filters
K242092 · DTM Filter, Blood,... · Cardiovascular
Nov 2024 124d
XTRA Collection sets; XTRA Sequestration set X
K241236 · CAC Apparatus, Autotransfusion · Cardiovascular
Aug 2024 106d
XTRA Autotransfusion System (with XTRA Bowl sets)
K240584 · CAC Apparatus, Autotransfusion · Cardiovascular
Apr 2024 59d
R501 - R502 aortic root cannulae with and without vent line (R501-15: R501-20: R501-26. R502-15; R502-20: R502-26)
K240193 · DWF Catheter, Cannula And... · Cardiovascular
Feb 2024 29d
D100 KIDS; D101 KIDS
K231652 · DTZ Oxygenator,... · Cardiovascular
Nov 2023 163d
BMR 1900 PHISIO
K223361 · DTN Reservoir, Blood,... · Cardiovascular
Jun 2023 219d
EOS PMP
K211495 · DTZ Oxygenator,... · Cardiovascular
Jul 2021 60d
R501 aortic root cannula without vent line, R502 aortic root cannula with vent line
K200612 · DWF Catheter, Cannula And... · Cardiovascular
Nov 2020 253d
Inspire 6M Hollow Fiber oxygenator, Inspire 7M Hollow Fiber oxygenator, Inspire 8M Hollow Fiber oxygenator
K201916 · DTZ Oxygenator,... · Cardiovascular
Aug 2020 34d
INSPIRE 7FM Hollow fiber oxygenator with integrated arterial filter, INSPIRE 7F Hollow fiber oxygenator with integrated arterial filter and hardshell reservoir, INSPIRE 7F DUAL Hollow fiber oxygenator with integrated arterial filter and hardshell reservoir
K200683 · DTZ Oxygenator,... · Cardiovascular
Jun 2020 88d
Revolution Centrifugal Blood Pump
K190650 · KFM Pump, Blood,... · Cardiovascular
Aug 2019 147d
INSPIRE 7 Hollow Fiber Oxygenator with integrated Hardshell/Venous Cardiotomy Reservoir, INSPIRE 7M Hollow Fiber Oxygenator, INSPIRE 7 Dual Hollow Fiber Oxygenator with integrated Hardshell/Venous Cardiotomy Reservoir
K190690 · DTZ Oxygenator,... · Cardiovascular
Apr 2019 26d
PureFlex Arterial Cannulae
K180979 · DWF Catheter, Cannula And... · Cardiovascular
Nov 2018 217d
MEMO 4D
K180411 · KRH Ring, Annuloplasty · Cardiovascular
Mar 2018 29d
INSPIRE 6M Hollow Fiber Oxygenator; INSPIRE 6F M Hollow Fiber Oxygenator with Integrated Arterial Filter; INSPIRE 8M Hollow Fiber Oxygenator; INSPIRE 8F M Hollow Fiber Oxygenator with Integrated Arterial Filter
K180448 · DTZ Oxygenator,... · Cardiovascular
Mar 2018 30d
Aortic Arch Cannulae, Optiflow Aortic Arch Cannulae
K162215 · DWF Catheter, Cannula And... · Cardiovascular
Jun 2017 312d
INSPIRE SVR 1200, INSPIRE 6F C, INSPIRE 8F C
K161733 · DTN Reservoir, Blood,... · Cardiovascular
Mar 2017 258d
LILLIPUP PMP, LILLIPUT PMP INTEGRATED
K151713 · DTZ Oxygenator,... · Cardiovascular
Nov 2015 134d
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