Venous Cardiopolmunary Bypass Cannula
35 catalogue numbers from RTS-11129, listed by Sorin Group Italia SRL, under Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
35catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (2), Jiangsu (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Gcmedica Enterprise Ltd.(Wuxi) | Wuxi | Jiangsu | Contract manufacturer | 55 |
| Modern Medical Equipment Manufacturing Ltd. | Heng Li, Dongguan | Guangdong | Contract manufacturer | 26 |
| Modern Medical Equipment Manufacturing (Qing Yuan) Ltd | Qing Yuan | Guangdong | Contract manufacturer | 26 |
Record
| Listed by | Sorin Group Italia SRL |
|---|---|
| FDA product code | DWF |
| Device type | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Device class | Class 2 |
| Regulation | 21 CFR 870.4210 |
| 510(k) | K943934 |
| Record published | 2025-12-19 |
| Record revised | 2026-03-19 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| RTS-11129 | In distribution | |
| RDS-61134 | In distribution | |
| RDS-61046 | In distribution | |
| RDS-61146 | In distribution | |
| RV-40020 | In distribution | |
| RV-40022 | In distribution | |
| RV-41028 | In distribution | |
| RDS-61037 | In distribution | |
| RV-41024 | In distribution | |
| RV-41030 | In distribution | |
| RV-41032 | In distribution | |
| RV-40030 | In distribution | |
| RV-41020 | In distribution | |
| RV-40024 | In distribution | |
| RV-41034 | In distribution | |
| RV-41026 | In distribution | |
| RV-40028 | In distribution | |
| RTS-13029 | In distribution | |
| RV-40536 | In distribution | |
| RV-41036 | In distribution | |
| RV-40034 | In distribution | |
| RDS-61137 | In distribution | |
| RV-40018 | In distribution | |
| RV-41018 | In distribution | |
| RV-41022 | In distribution | |
| RV-40036 | In distribution | |
| RV-40026 | In distribution | |
| RDS-61150 | In distribution | |
| RTS-13129 | In distribution | |
| RDS-61140 | In distribution | |
| RV-40016 | In distribution | |
| RDS-61040 | In distribution | |
| RTS-11029 | In distribution | |
| RDS-61034 | In distribution | |
| RV-40032 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | Medtronic, Inc. | 5,237 |
| DLP™ | Medtronic, Inc. | 804 |
| Bio-Medicus™ | Medtronic, Inc. | 223 |
| Pemco Inc | Pemco, Inc. | 137 |
| Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | Maquet Cardiopulmonary GmbH | 135 |
| Venous cardiopulmonary bypass cannula | LivaNova USA, Inc. | 97 |
| Eopa™ | Medtronic, Inc. | 87 |
| Surge Cardiovascular | MED Michigan Holdings LLC | 80 |
| Arterial cardiopulmonary bypass cannula | LivaNova USA, Inc. | 79 |
| MC2™ | Medtronic, Inc. | 66 |
| Select Series® | Medtronic, Inc. | 63 |
| Edwards Lifesciences Aortic Perfusion Cannula | Edwards Lifesciences Technology Sarl | 52 |
Showing 12 of 372. All products under Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Recalls Naming This Product
4 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| LivaNova USA, Inc. | 510(k) number | 2017-06-09 | Class II | Process control | Identification of excess plastic on the tip of the cannula. | 105,770 units | 2023-11-09 |
| LivaNova USA, Inc. | 510(k) number | 2016-08-12 | Class II | Process control | Sorin Group USA, Inc. announces a voluntary field for the Aortic Arch Cannula and Coronary Artery Perfusion Cannula With Ballon because the tip of the cannula should be bent at either a 45 or 90 degree angle. Samples have been returned wher | 200 units worldwide | 2017-03-27 |
| LivaNova USA, Inc. | 510(k) number | 2016-06-22 | Class II | Process control | Sorin Group USA is recalling Aortic Arch Cannulae (part numbers NA-55X7 and NA-55X8) because the distal end may be less than specified. The defective cannula are showing an angle that is about 15-20 degrees instead of approximately 45 degr | 5740 | 2017-03-27 |
| LivaNova USA, Inc. | 510(k) number | 2016-01-25 | Class II | Employee error | Sorin Group initiated field correction for the Dual Stage Venous Return Catheter because the incorrect Instructions For Use (IFU) was packaged in the case. | 60 | 2016-10-24 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.