ClearanceBrief
Company ยท US

Sorin Group USA, Inc.

FDA 510(k) clearances and medical device recalls filed under this name, 2010 to 2013. Name variants (Inc, Corp, punctuation) are merged.

2510(k) clearances (0 in 12 months)
135recalls (0 in 12 months)
130recalls that name a 510(k)

Product codes

CodeDeviceRecords
DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass47
DTQConsole, Heart-Lung Machine, Cardiopulmonary Bypass28
DWETubing, Pump, Cardiopulmonary Bypass16
DWCController, Temperature, Cardiopulmonary Bypass14
DTZOxygenator, Cardiopulmonary Bypass12
GEIElectrosurgical, Cutting & Coagulation & Accessories8
KFMPump, Blood, Cardiopulmonary Bypass, Non-Roller Type3
DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass2
DWAControl, Pump Speed, Cardiopulmonary Bypass2
KRGProgrammer, Pacemaker2
GATSuture, Nonabsorbable, Synthetic, Polyethylene1
LWRHeart-Valve, Non-Allograft Tissue1
MRMDefibrillator, Implantable, Dual-Chamber1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
May 21, 2013K122735SORIN VASCULOOP TWO TIE ENDOSCOPIC LIGATION SYSTEM MODEL DTTS2
Sorin Group USA, Inc.
GAT
Nov 1, 2010K102983VASCUCLEAR PRECISION BIPOLAR
Sorin Group USA, Inc.
GEI

Latest recalls

DateFirm and productCodeLinked 510(k)
Sep 28, 2017Sorin Group USA, Inc.
FlexFlow Venous Cannula Model/Catalog Number 200-200 The FlexFlow Venous Cannula is a single use sterile device. It is a size 23 French with an outside diameter of 0.30 inch (7.7 mm) and an effective
Terminated
DWFK052081
Jul 25, 2017Sorin Group USA, Inc.
STOCKERT Heater-Cooler System 3T, 200V/50 Hz/60 Hz
Terminated
DWCK052601
Jul 25, 2017Sorin Group USA, Inc.
STOCKERT Heater-Cooler System 3T, 120V/60 Hz
Terminated
DWCK052601
Jul 25, 2017Sorin Group USA, Inc.
STOCKERT Heater-Cooler System 3T, 127V/60 Hz
Terminated
DWCK052601
Jul 25, 2017Sorin Group USA, Inc.
STOCKERT Heater-Cooler System 3T, 208V/60 Hz
Terminated
DWCK052601
Jul 25, 2017Sorin Group USA, Inc.
STOCKERT Heater-Cooler System 3T, 240V/60 Hz
Terminated
DWCK052601
Jul 25, 2017Sorin Group USA, Inc.
STOCKERT Heater-Cooler System 3T, 230 V
Terminated
DWCK052601
Jun 29, 2017Sorin Group USA, Inc.
NON-STERILE SAMPLE, SORIN GROUP, SMART PERFUSION PACK, REF 627376401, 1 EA, NOT FOR CLINICAL USE
Terminated
DWEK981613
Jun 29, 2017Sorin Group USA, Inc.
NON-STERILE SAMPLE, SORIN GROUP, SMART CARDIOPLEGIA, CARDIOPLEGIA PACK, REF 627366901, 1 EA, NOT FOR CLINICAL USE
Terminated
DWEK981613
Jun 29, 2017Sorin Group USA, Inc.
NON-STERILE SAMPLE, SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8FS, REF 044043700, 1 EA, NOT FOR CLINICAL USE
Terminated
DWEK981613
Jun 29, 2017Sorin Group USA, Inc.
SORIN GROUP, SMART PERFUSION PACK, SMART 1/4" PEDS PACK, REF 627262502, STERILE EO, Rx Only, 1 EA
Terminated
DWEK981613
Jun 29, 2017Sorin Group USA, Inc.
SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8S, REF 044036101, STERILE EO, Rx Only, 1 EA
Terminated
DWEK981613
Jun 29, 2017Sorin Group USA, Inc.
SORIN GROUP, SMART PERFUSION PACK, TOTAL VISION SYSTEM-SMA, REF 084510101, STERILE EO, Rx Only, 1 EA
Terminated
DWEK981613
Jun 29, 2017Sorin Group USA, Inc.
SORIN GROUP, SMART PERFUSION PACK, NEONATE/PEDIATRIC PACK, REF 627127702, STERILE EO, Rx Only, 1 EA
Terminated
DWEK981613
Jun 29, 2017Sorin Group USA, Inc.
STERILE SAMPLE SORIN GROUP, SMART PERFUSION PACK, NEONATE/PEDIATRIC PACK, REF 627127703, STERILE EO, Rx Only, 1 EA
Terminated
DWEK981613
Jun 29, 2017Sorin Group USA, Inc.
SORIN GROUP, SMART PERFUSION PACK, SMART 3/16" PEDS PACK, REF 627263601, STERILE EO, Rx Only, 1 EA
Terminated
DWEK981613
Jun 29, 2017Sorin Group USA, Inc.
SORIN GROUP, SMART PERFUSION PACK, PUMP AND TABLE PACK, REF 627374101, STERILE EO, Rx Only, 1 EA
Terminated
DWEK981613
Jun 29, 2017Sorin Group USA, Inc.
SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8FS S5 PACK W/CARDIOPLEGIA-3D, (a) REF 044042600 AND (b) REF 044011200, STERILE EO, Rx Only, 1 EA
Terminated
DWEK981613
Jun 29, 2017Sorin Group USA, Inc.
SORIN GROUP, SMART PERFUSION PACK, SMART VENOUS VACUUM, REF 084118102, STERILE EO, Rx Only, 1 EA
Terminated
DWEK981613
Jun 29, 2017Sorin Group USA, Inc.
SORIN GROUP, SMART PERFUSION PACK, INSPIRE 6FS, REF 044008204, STERILE EO, Rx Only, 1 EA
Terminated
DWEK981613
Jun 29, 2017Sorin Group USA, Inc.
SORIN GROUP, SMART PERFUSION PACK, SMA PRIMO2X OPTI PACK, REF 088512900, STERILE EO, Rx Only, 1 EA
Terminated
DWEK981613
Jun 29, 2017Sorin Group USA, Inc.
SORIN GROUP, SMART PERFUSION PACK, SMART CIRCULATORY ASSIST PACK, REF 627255003, STERILE EO, Rx Only, 1 EA
Terminated
DWEK981613
Jun 29, 2017Sorin Group USA, Inc.
SORIN GROUP, SMART PERFUSION PACK, LONG PACK, REF 088512600, STERILE EO, Rx Only, 1 EA
Terminated
DWEK981613
Jun 9, 2017Sorin Group USA, Inc.
Sorin Group Aortic Arch Cannula, 7 mm x 10 in x 3/8 in, Rx Only, Sterile Product Usage: The Aortic Arch Cannulae are indicated for use in perfusion of the ascending aorta during cardiopulmonary by
Terminated
DWFK943934
Dec 1, 2016Sorin Group USA, Inc.
STCKERT HeaterCooler System 3T; Item Number 160281, HeaterCooler 3T, 240V/60Hz; Item Number 160282, HeaterCooler 3T, 208V/60Hz; Item Number 160285, HeaterCooler 3T, 120V/ 60Hz The Heater Cooler 3T is
Terminated
DWCK052601
Oct 31, 2016Sorin Group USA, Inc.
Perceval Sutureless Aortic Heart Valve size S, Item # ICV1208, REF PVS21; Perceval Sutureless Aortic Heart Valve size M, Item # ICV1209, REF PVS23; Perceval Sutureless Aortic Heart Valve size L, Item
Terminated
LWRNone listed
Sep 29, 2016Sorin Group USA, Inc.
The ORCHESTRA PLUS Programmer A portable device, equipped with a microprocessor used to program and interrogate Sorin implantable pacemakers and defibrillators. The programmer also provides measurem
Terminated
KRGNone listed
Sep 29, 2016Sorin Group USA, Inc.
The ORCHESTRA Programmer A portable device, equipped with a microprocessor used to program and interrogate Sorin implantable pacemakers and defibrillators. The programmer also provides measurement,
Terminated
KRGNone listed
Sep 21, 2016Sorin Group USA, Inc.
Stckert S5 System, S5 Heart-lung machine, Cardiopulmonary bypass heart-lung machine console Product Usage: The Stckert S5 System is intended to be used during cardiopulmonary bypass for procedures la
Terminated
DTQK071318
Sep 8, 2016Sorin Group USA, Inc.
Coronary Artery Perfusion Cannula with Balloon (part number CP-2200X). The Coronary Artery Perfusion Cannula with Balloon The Cannula consists of a single lumen vinyl tube provided for with a vinyl fe
Terminated
DWFK030231
K972503
Sep 8, 2016Sorin Group USA, Inc.
Aortic Arch Cannula and Coronary Artery Perfusion Cannula with Ballon (part number NA-55X6). The Aortic Arch Cannulae are designed to be used in the extracorporeal circuit during cardiopulmonary bypas
Terminated
DWFK943934
Jul 8, 2016Sorin Group USA, Inc.
AORTIC ARCH CANNULA, Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (part numbers NA-55X7 and NA-55X8) Aortic Arch Cannulae are designed to be used in the extracorporeal circuit durin
Terminated
DWFK943934
Mar 17, 2016Sorin Group USA, Inc.
Stockert Heater-Cooler 3T; Item Number 16-02-8, H3T/240V/60Hz ; 16-02-82, H3T208V/60Hz ; 16-02-85, H3T/120V/60Hz. Device Listing E572259
Terminated
DWCK052601
Feb 16, 2016Sorin Group USA, Inc.
Dual Stage Venous Return Catheter, Low-Profile, wire reinforced (36F/46F, Sterile), Model Number: LRD-61046, Expiration 10/31/2018, Product is packed in a sealed pouch, ten (10) pouches per case. Car
Terminated
DWFK943934
Jan 19, 2016Sorin Group USA, Inc.
CDI H/S Cuvette, non-sterile, Manufactured by Terumo Cardiovascular Group, Perfusion Pack or Smart Perfusion Pack. Product Usage: Heart/Lung Perfusion Pack is either a customized tubing pack built
Terminated
DWFK881330
Jul 15, 2015Sorin Group USA, Inc.
Sorin Stockert Heater-Cooler 3T, 200 V / 50Hz / 60 Hz Temperature control for extracorporeal perfusion of durations up to 6 hours.
Terminated
DWCK052601
Jul 15, 2015Sorin Group USA, Inc.
Sorin Stockert Heater-Cooler 3T, 120 V / 60 Hz Temperature control for extracorporeal perfusion of durations up to 6 hours.
Terminated
DWCK052601
Jul 15, 2015Sorin Group USA, Inc.
Sorin Stockert Heater-Cooler 3T, 127 V / 60 Hz Temperature control for extracorporeal perfusion of durations up to 6 hours.
Terminated
DWCK052601
Jul 15, 2015Sorin Group USA, Inc.
Sorin Stockert Heater-Cooler 3T, 208 V / 60 Hz Temperature control for extracorporeal perfusion of durations up to 6 hours.
Terminated
DWCK052601
Jul 15, 2015Sorin Group USA, Inc.
Sorin Stockert Heater-Cooler 3T, 240 V / 60 Hz Temperature control for extracorporeal perfusion of durations up to 6 hours.
Terminated
DWCK052601
Jul 15, 2015Sorin Group USA, Inc.
Sorin Stockert Heater-Cooler 3T, 230 V Temperature control for extracorporeal perfusion of durations up to 6 hours.
Terminated
DWCK052601
Aug 20, 2013Sorin Group USA, Inc.
Edwards Lifesciences Suction Wand Model S099B, packaged in Sorin Group Heart/Lung Perfusion Packs.
Terminated
DWFK881330
Mar 8, 2013Sorin Group USA, Inc.
Isoline Implantable Defibrillation Lead, Model Isoline 2CR5, 2CR6 and 2CT6. These lead models are indicated for ventricular antitachycardia pacing and ventricular defibrillation for automated treatme
Terminated
MRMNone listed
Nov 8, 2012Sorin Group USA, Inc.
Sorin C5 Perfusion System, Item number 58-00-00 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six hours or less.
Terminated
DTQK071318
K093882
Nov 8, 2012Sorin Group USA, Inc.
S5 Mast Roller Pump 150, Item Number: 10-88-00 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six hours or less.
Terminated
DTQK071318
K093882
Nov 8, 2012Sorin Group USA, Inc.
S5 Mast Roller Pump 85, Item Number: 10-88-60 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six hours or less.
Terminated
DTQK071318
K093882
Nov 8, 2012Sorin Group USA, Inc.
S5 Double Roller Pump 85, Item Number: 10-85-00 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six hours or less.
Terminated
DTQK071318
K093882
Nov 8, 2012Sorin Group USA, Inc.
S5 Single Roller Pump 150, Item Number: 10-80-00 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six hours or less.
Terminated
DTQK071318
K093882
Oct 29, 2012Sorin Group USA, Inc.
SCP Pump Control Panel, Product Code: 60-02-50, Serial Numbers: 60S09131, 60S09133-60S09135, 60S09140-60S09142, 60S08954. The SCP is a cardiopulmonary bypass speed control device indicated for use ex
Terminated
DWAK011838
Oct 29, 2012Sorin Group USA, Inc.
SCP Pump Control Panel, Product Code: 60-02-15, Serial Numbers: 60S09121, 60S09123-60S09129, 60S09136-60S09139. The SCP is a cardiopulmonary bypass speed control device indicated for use exclusively
Terminated
DWAK011838

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