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
| Code | Device | Records |
|---|---|---|
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | 47 |
| DTQ | Console, Heart-Lung Machine, Cardiopulmonary Bypass | 28 |
| DWE | Tubing, Pump, Cardiopulmonary Bypass | 16 |
| DWC | Controller, Temperature, Cardiopulmonary Bypass | 14 |
| DTZ | Oxygenator, Cardiopulmonary Bypass | 12 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 8 |
| KFM | Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type | 3 |
| DTL | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | 2 |
| DWA | Control, Pump Speed, Cardiopulmonary Bypass | 2 |
| KRG | Programmer, Pacemaker | 2 |
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | 1 |
| LWR | Heart-Valve, Non-Allograft Tissue | 1 |
| MRM | Defibrillator, Implantable, Dual-Chamber | 1 |
Latest 510(k) clearances
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 28, 2017 | Sorin 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 |
DWF | K052081 |
| Jul 25, 2017 | Sorin Group USA, Inc. STOCKERT Heater-Cooler System 3T, 200V/50 Hz/60 Hz Terminated |
DWC | K052601 |
| Jul 25, 2017 | Sorin Group USA, Inc. STOCKERT Heater-Cooler System 3T, 120V/60 Hz Terminated |
DWC | K052601 |
| Jul 25, 2017 | Sorin Group USA, Inc. STOCKERT Heater-Cooler System 3T, 127V/60 Hz Terminated |
DWC | K052601 |
| Jul 25, 2017 | Sorin Group USA, Inc. STOCKERT Heater-Cooler System 3T, 208V/60 Hz Terminated |
DWC | K052601 |
| Jul 25, 2017 | Sorin Group USA, Inc. STOCKERT Heater-Cooler System 3T, 240V/60 Hz Terminated |
DWC | K052601 |
| Jul 25, 2017 | Sorin Group USA, Inc. STOCKERT Heater-Cooler System 3T, 230 V Terminated |
DWC | K052601 |
| Jun 29, 2017 | Sorin Group USA, Inc. NON-STERILE SAMPLE, SORIN GROUP, SMART PERFUSION PACK, REF 627376401, 1 EA, NOT FOR CLINICAL USE Terminated |
DWE | K981613 |
| Jun 29, 2017 | Sorin Group USA, Inc. NON-STERILE SAMPLE, SORIN GROUP, SMART CARDIOPLEGIA, CARDIOPLEGIA PACK, REF 627366901, 1 EA, NOT FOR CLINICAL USE Terminated |
DWE | K981613 |
| Jun 29, 2017 | Sorin Group USA, Inc. NON-STERILE SAMPLE, SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8FS, REF 044043700, 1 EA, NOT FOR CLINICAL USE Terminated |
DWE | K981613 |
| Jun 29, 2017 | Sorin Group USA, Inc. SORIN GROUP, SMART PERFUSION PACK, SMART 1/4" PEDS PACK, REF 627262502, STERILE EO, Rx Only, 1 EA Terminated |
DWE | K981613 |
| Jun 29, 2017 | Sorin Group USA, Inc. SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8S, REF 044036101, STERILE EO, Rx Only, 1 EA Terminated |
DWE | K981613 |
| Jun 29, 2017 | Sorin Group USA, Inc. SORIN GROUP, SMART PERFUSION PACK, TOTAL VISION SYSTEM-SMA, REF 084510101, STERILE EO, Rx Only, 1 EA Terminated |
DWE | K981613 |
| Jun 29, 2017 | Sorin Group USA, Inc. SORIN GROUP, SMART PERFUSION PACK, NEONATE/PEDIATRIC PACK, REF 627127702, STERILE EO, Rx Only, 1 EA Terminated |
DWE | K981613 |
| Jun 29, 2017 | Sorin Group USA, Inc. STERILE SAMPLE SORIN GROUP, SMART PERFUSION PACK, NEONATE/PEDIATRIC PACK, REF 627127703, STERILE EO, Rx Only, 1 EA Terminated |
DWE | K981613 |
| Jun 29, 2017 | Sorin Group USA, Inc. SORIN GROUP, SMART PERFUSION PACK, SMART 3/16" PEDS PACK, REF 627263601, STERILE EO, Rx Only, 1 EA Terminated |
DWE | K981613 |
| Jun 29, 2017 | Sorin Group USA, Inc. SORIN GROUP, SMART PERFUSION PACK, PUMP AND TABLE PACK, REF 627374101, STERILE EO, Rx Only, 1 EA Terminated |
DWE | K981613 |
| Jun 29, 2017 | Sorin 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 |
DWE | K981613 |
| Jun 29, 2017 | Sorin Group USA, Inc. SORIN GROUP, SMART PERFUSION PACK, SMART VENOUS VACUUM, REF 084118102, STERILE EO, Rx Only, 1 EA Terminated |
DWE | K981613 |
| Jun 29, 2017 | Sorin Group USA, Inc. SORIN GROUP, SMART PERFUSION PACK, INSPIRE 6FS, REF 044008204, STERILE EO, Rx Only, 1 EA Terminated |
DWE | K981613 |
| Jun 29, 2017 | Sorin Group USA, Inc. SORIN GROUP, SMART PERFUSION PACK, SMA PRIMO2X OPTI PACK, REF 088512900, STERILE EO, Rx Only, 1 EA Terminated |
DWE | K981613 |
| Jun 29, 2017 | Sorin Group USA, Inc. SORIN GROUP, SMART PERFUSION PACK, SMART CIRCULATORY ASSIST PACK, REF 627255003, STERILE EO, Rx Only, 1 EA Terminated |
DWE | K981613 |
| Jun 29, 2017 | Sorin Group USA, Inc. SORIN GROUP, SMART PERFUSION PACK, LONG PACK, REF 088512600, STERILE EO, Rx Only, 1 EA Terminated |
DWE | K981613 |
| Jun 9, 2017 | Sorin 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 |
DWF | K943934 |
| Dec 1, 2016 | Sorin 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 |
DWC | K052601 |
| Oct 31, 2016 | Sorin 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 |
LWR | None listed |
| Sep 29, 2016 | Sorin 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 |
KRG | None listed |
| Sep 29, 2016 | Sorin 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 |
KRG | None listed |
| Sep 21, 2016 | Sorin 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 |
DTQ | K071318 |
| Sep 8, 2016 | Sorin 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 |
DWF | K030231 K972503 |
| Sep 8, 2016 | Sorin 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 |
DWF | K943934 |
| Jul 8, 2016 | Sorin 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 |
DWF | K943934 |
| Mar 17, 2016 | Sorin 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 |
DWC | K052601 |
| Feb 16, 2016 | Sorin 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 |
DWF | K943934 |
| Jan 19, 2016 | Sorin 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 |
DWF | K881330 |
| Jul 15, 2015 | Sorin 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 |
DWC | K052601 |
| Jul 15, 2015 | Sorin Group USA, Inc. Sorin Stockert Heater-Cooler 3T, 120 V / 60 Hz
Temperature control for extracorporeal perfusion of durations up to 6 hours. Terminated |
DWC | K052601 |
| Jul 15, 2015 | Sorin Group USA, Inc. Sorin Stockert Heater-Cooler 3T, 127 V / 60 Hz
Temperature control for extracorporeal perfusion of durations up to 6 hours. Terminated |
DWC | K052601 |
| Jul 15, 2015 | Sorin Group USA, Inc. Sorin Stockert Heater-Cooler 3T, 208 V / 60 Hz
Temperature control for extracorporeal perfusion of durations up to 6 hours. Terminated |
DWC | K052601 |
| Jul 15, 2015 | Sorin Group USA, Inc. Sorin Stockert Heater-Cooler 3T, 240 V / 60 Hz
Temperature control for extracorporeal perfusion of durations up to 6 hours. Terminated |
DWC | K052601 |
| Jul 15, 2015 | Sorin Group USA, Inc. Sorin Stockert Heater-Cooler 3T, 230 V
Temperature control for extracorporeal perfusion of durations up to 6 hours. Terminated |
DWC | K052601 |
| Aug 20, 2013 | Sorin Group USA, Inc. Edwards Lifesciences Suction Wand Model S099B, packaged in Sorin Group Heart/Lung Perfusion Packs. Terminated |
DWF | K881330 |
| Mar 8, 2013 | Sorin 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 |
MRM | None listed |
| Nov 8, 2012 | Sorin 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 |
DTQ | K071318 K093882 |
| Nov 8, 2012 | Sorin 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 |
DTQ | K071318 K093882 |
| Nov 8, 2012 | Sorin 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 |
DTQ | K071318 K093882 |
| Nov 8, 2012 | Sorin 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 |
DTQ | K071318 K093882 |
| Nov 8, 2012 | Sorin 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 |
DTQ | K071318 K093882 |
| Oct 29, 2012 | Sorin 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 |
DWA | K011838 |
| Oct 29, 2012 | Sorin 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 |
DWA | K011838 |
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