Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9680841

FEI Number

3005426550

Entity Name

SORIN GROUP ITALIA S.R.L

City/State/Country

MIRANDOLA Modena, IT

Establishment Address

86, VIA STATALE 12 NORD, MIRANDOLA Modena 41037, IT

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

SORIN GROUP ITALIA S.R.L (Owner Number: 9011842)

Owner / Operator Contact Address

86, VIA STATALE 12 NORD, --, MIRANDOLA (MO), IT-MO 41037, IT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K041061

PMA Number

N/A

All Registered Proprietary Names

INSPIRE 6F INSPIRE 6F M INSPIRE HVR D733 MICRO 40 Ph.I.S.I.O. D731 MICRO 27 Ph.I.S.I.O. COD. 151 COD. 150 Femoral arterial cannula set 17 fr INSPIRE HVR INSPIRE 8M INSPIRE 8 Dual Stage Venous Return Cannulae CSC14 XTRA Sequestration and Collection sets SMARxT BCD Vanguard System KIDS D101 KIDS D100 KIDS D101 M KIDS D100 M Protek Duo 31 Fr Mini Femoral arterial cannula set 15 Fr D734 MICRO 40 D732 MICRO 27 Revolution MICRO Arterial Filters INSPIRE 8M INSPIRE 8 DUAL INSPIRE HVR DUAL INSPIRE 7F Hollow fiber oxygenator with integrated arterial filter and hardshell reservoir INSPIRE 7F M oxgenator with integrated arterial filter INSPIRE 7F DUAL Hollow fiber oxygenator with integrated arterial filter and hardshell reservoir INSPIRE 6F M INSPIRE HVR DUAL INSPIRE 6 DUAL INSPIRE 6F DUAL INSPIRE 6M D920, Lilliput 1 twin reservoir Ventricular Vent Catheter (VT-XXXXX) Coronary Sinus Cannula (RCM-XXXXX) XTRA Bowl sets Revolution PC D736 MICRO 40 D735 MICRO 20 Femoral arterial cannula set 14 fr D131 Ph.I.S.l.O. Dideco Kids D734 MICRO 40 Ph.I.S.I,O. Transeptal cannula set EF 72 Venous Cardiopolmunary Bypass Cannula (RV-XXXXX) A272-xx Aortic Arch Cannulae, Optiflow Aortic Arch Cannulae A211-xx A/B/C/D/E/F/N series A232-xx D/E/F series A262-xx A/B/C/D/E/F series A222-xx A/B/C/D/E/F/N series A212-73 A/B/C/D/E/F A212-xx A/B/C/D/E/F/N series LINEA ASPIRAZIONE XTRA PROCEDURE SET TX/175 PROCEDURE SET TX/125 BOWL SET X/225 PROCEDURE SET TX/225 PROCEDURE SET BX/125 BOWL SET X/125 BOWL SET X/175 PROCEDURE SET BX/225 PROCEDURE SET TX/55 PROCEDURE SET BX/55 PROCEDURE SET BX/175 BOWL SET X/55 XTRA Autotransfusion Cell Separator XRES T with preconnected cardio kit COLLECTION SET BX CARDIO SEQUESTRATION SET X COLLECTION SET TX CARDIO COLLECTION SET TX COLLECTION SET BX V122-xx BMR1900 SMARxT Protek venous dilator set D762 D752 D754 D764 D100 DIDECO KIDS M PHISIO D120 DIDECO KIDS R PHISIO D100 DIDECO KIDS PHISIO KIDS Arterial Filters BMR1900 Phisio Protek Duo 31 Fr Protek Duo 29 Fr Preotek Duo 31 Fr RD XRES T XRES B INSPIRE 8F DUAL INSPIRE 8F M INSPIRE HVR DUAL V38SAT V12SAT BRAT 2 processing sets Reservoir Outlet Clamp Coronary Sinus Cannula (RCS-XXXXX) B-Capta P615-xx P607-xx P608-xx P606-xx P605-xx P616-xx P617-xx P618-xx CARD 43 Cardioplegia Cannula (VC/AR/AX - XXXXX) INSPIRE HVR INSPIRE 8F INSPIRE 8F M Vanguard Blood Cardioplegia Systems R502-xx R501-xx D732 MICRO 27 PH.I.S.I.O. Inspire HCR cardiotomy reservoir Inspire HCR DUAL cardiotomy reservoir D101 DIDECO KIDS PHISIO D101 DIDECO KIDS M PHISIO D121 DIDECO KIDS R PHISIO EOS PMP EOS PMP INTEGRATED Cardiotomy reservoir without filter Cardiotomy reservoir with filter INSPIRE SVR 1200 A232-xx A/B/C/N series A221-xx A/B/C/D/E/F/N series A261-xx A/B/C/D/E/F/N series A231-xx A/B/C/D/E/F/N series DHF 0.6 DHF 0.2 Protek Duo 29 Fr ProtekDilate Vascular Access Kit TANDEM RESERVOIR "Y" Electa WS-125E WS-225E WS-175E WS-55E INSPIRE 7 INSPIRE 7 DUAL INSPIRE 7 M Hemoconcentrators D903 AVANT HOLLOW FIBER OXYGENATOR D970 DIDECO AVANT RESERVOIR INSPIRE 6 INSPIRE HVR INSPIRE 6M WCB-10 D130 Ph.I.S.I.O. Dideco Kids R501-R502 aortic root cannulae D731 MICRO 27 D733 MICRO 40

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DTZ	Oxygenator, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4350	2012-07-05
DTM	Filter, Blood, Cardiopulmonary Bypass, Arterial Line	Cardiovascular	Class 2	870.4260	2012-10-15
CAC	Apparatus, Autotransfusion	Anesthesiology	Class 2	868.5830	2012-10-15
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2024-07-10
DTZ	Oxygenator, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4350	2012-09-13
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2026-02-02
DTR	Heat-Exchanger, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4240	2012-10-12
CAC	Apparatus, Autotransfusion	Anesthesiology	Class 2	868.5830	2024-09-04
DTN	Reservoir, Blood, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4400	2024-09-04
DTR	Heat-Exchanger, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4240	2007-07-10
DTZ	Oxygenator, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4350	2023-11-20
DTR	Heat-Exchanger, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4240	2023-11-20
DTN	Reservoir, Blood, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4400	2023-11-20
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2024-07-10
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2024-07-10
DTM	Filter, Blood, Cardiopulmonary Bypass, Arterial Line	Cardiovascular	Class 2	870.4260	2012-10-12
KFM	Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type	Cardiovascular	Class 2	870.4360	2009-10-16
DTM	Filter, Blood, Cardiopulmonary Bypass, Arterial Line	Cardiovascular	Class 2	870.4260	2025-02-03
DTZ	Oxygenator, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4350	2012-07-27
DTN	Reservoir, Blood, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4400	2020-06-16
DTZ	Oxygenator, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4350	2020-06-16
DTM	Filter, Blood, Cardiopulmonary Bypass, Arterial Line	Cardiovascular	Class 2	870.4260	2020-06-16
DTP	Defoamer, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4230	2020-06-16
DTR	Heat-Exchanger, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4240	2020-06-16
DTN	Reservoir, Blood, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4400	2012-07-27
DTZ	Oxygenator, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4350	2012-07-27
DTP	Defoamer, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4230	2015-07-09
DTN	Reservoir, Blood, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4400	2015-07-09
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2025-12-05
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2025-12-05
CAC	Apparatus, Autotransfusion	Anesthesiology	Class 2	868.5830	2024-09-04
KFM	Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type	Cardiovascular	Class 2	870.4360	2009-10-16
DTM	Filter, Blood, Cardiopulmonary Bypass, Arterial Line	Cardiovascular	Class 2	870.4260	2012-10-15
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2024-07-10
DTM	Filter, Blood, Cardiopulmonary Bypass, Arterial Line	Cardiovascular	Class 2	870.4260	2012-10-15
DTM	Filter, Blood, Cardiopulmonary Bypass, Arterial Line	Cardiovascular	Class 2	870.4260	2012-10-12
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2024-07-10
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2025-12-05
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2011-10-24
DTZ	Oxygenator, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4350	2018-12-03
DQR	Cannula, Catheter	Cardiovascular	Class 2	870.1300	2007-07-10
CAC	Apparatus, Autotransfusion	Anesthesiology	Class 2	868.5830	2010-10-19
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2012-09-03
DTN	Reservoir, Blood, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4400	2009-10-16
DRE	Dilator, Vessel, For Percutaneous Catheterization	Cardiovascular	Class 2	870.1310	2024-07-10
DTN	Reservoir, Blood, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4400	2012-10-12
DTZ	Oxygenator, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4350	2009-10-16
DTM	Filter, Blood, Cardiopulmonary Bypass, Arterial Line	Cardiovascular	Class 2	870.4260	2025-02-03
DTN	Reservoir, Blood, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4400	2012-09-03
PZS	Dual Lumen Ecmo Cannula	Cardiovascular	Class 2	870.4100	2024-07-10
DTN	Reservoir, Blood, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4400	2010-04-06
DTZ	Oxygenator, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4350	2012-10-18
DTN	Reservoir, Blood, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4400	2012-10-18
DTQ	Console, Heart-Lung Machine, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4220	2009-12-18
CAC	Apparatus, Autotransfusion	Anesthesiology	Class 2	868.5830	2009-10-16
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2025-12-05
DRY	Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4330	2021-04-09
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2007-01-23
DTN	Reservoir, Blood, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4400	2012-10-15
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2025-12-05
DTZ	Oxygenator, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4350	2012-09-13
DTR	Heat-Exchanger, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4240	2025-07-02
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2012-04-18
DTM	Filter, Blood, Cardiopulmonary Bypass, Arterial Line	Cardiovascular	Class 2	870.4260	2012-10-15
DTN	Reservoir, Blood, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4400	2025-12-23
DTZ	Oxygenator, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4350	2009-10-16
DTZ	Oxygenator, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4350	2013-06-12
DTZ	Oxygenator, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4350	2015-06-16
DTZ	Oxygenator, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4350	2013-06-12
DTP	Defoamer, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4230	2009-02-25
DTN	Reservoir, Blood, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4400	2017-03-13
DQR	Cannula, Catheter	Cardiovascular	Class 2	870.1300	2012-09-05
KDI	Dialyzer, High Permeability With Or Without Sealed Dialysate System	Gastroenterology, Urology	Class 2	876.5860	2007-11-13
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2024-07-10
DRE	Dilator, Vessel, For Percutaneous Catheterization	Cardiovascular	Class 2	870.1310	2025-12-23
CAC	Apparatus, Autotransfusion	Anesthesiology	Class 2	868.5830	2007-11-13
DTZ	Oxygenator, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4350	2019-05-02
KDI	Dialyzer, High Permeability With Or Without Sealed Dialysate System	Gastroenterology, Urology	Class 2	876.5860	2025-05-06
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2015-07-09
DTZ	Oxygenator, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4350	2012-04-18
CAC	Apparatus, Autotransfusion	Anesthesiology	Class 2	868.5830	2015-04-27
DTM	Filter, Blood, Cardiopulmonary Bypass, Arterial Line	Cardiovascular	Class 2	870.4260	2012-10-15
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2025-03-04
DTM	Filter, Blood, Cardiopulmonary Bypass, Arterial Line	Cardiovascular	Class 2	870.4260	2007-11-13

Official Correspondent

LUIGI VECCHI

US Agent Details

Jennifer Houck Email: jennifer.houck@livanova.com Phone: (717) 3838558

Related Public Records

Same Entity

SORIN GROUP ITALIA S.R.L

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K914791	Gish Biomedical, Inc.	GISH ARTERIAL FILTER	1993-04-06
K790435	Surgikos, Inc.	*INTERSEPT BLOOD FILTER W/ TUBING BYPASS**	1979-03-27
K881350	Stryker Corp.	CBC/CONSTAVAC BLOOD CONSERVATION SYSTEM	1988-09-30
K832124	Med-West, Inc.	CPC, COUBLE LUMEN CARDIOPLEGIA-AIR ASPI	1983-08-12
K162500	Spyder Medical	Ostial Sprit Cannulae	2017-01-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-2022	Medtronic Perfusion Systems	2	Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Sterile; and Model number 96551, Venous Insertion Kit, Sterile.
Z-0021-2018	OriGen Biomedical, Inc.	2	The OriGen Reinforced Dual Lumen catheter (RDLC) is a duel lumen catheter with a wire reinforcement layer on the tip of the device. A thin sheath is used to cover and secure the wire layer and is heat shrunk into a permanent position.
Z-0001-2017	Terumo Cardiovascular Systems Corporation	2	CDI H/S Cuvette The intended use for the CDI H IS Cuvette is as follows: The CDI H/S Cuvettes are intended for use with a CDI monitor during cardiopulmonary bypass procedures when continuous monitoring of blood hematocrit and oxygen saturation is desired.
Z-0019-2025	Outset Medical, Inc.	2	Tablo Console, REF: PN-0003000, PN-0006000, part of the Tablo Hemodialysis System. The Tablo Hemodialysis System is indicated for use in patients with acute and/or chronic renal failure, with or without ultrafiltration, in an acute or chronic care facility.
Z-0028-2024	Fresenius Medical Care Holdings, Inc.	2	2008T Hemodialysis SYS, with CDX

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9680841. Last updated year: 2026. Please use registration number 9680841 when referencing this establishment in official correspondence.