Argyle
Left Ventricular Catheter,Ferguson, Radiopaque Line and Eye
3manufacturers in China registered for this device type
25catalogue 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 | Cardinal Health, United States |
|---|---|
| FDA product code | DWF |
| Device type | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Device class | Class 2 |
| Regulation | 21 CFR 870.4210 |
| Establishment | Contract manufacturer, Reprocessor, Contract steriliser, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-09-24 |
| Record revised | 2025-12-31 (version 10) |
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 |
| Storage | Special storage condition: Keep dry;AVOID DIRECT SUNLIGHT |
| Packaging | Case of 10, case of 40 |
| Sizes | Catheter gauge 10 to 24 Fr; length 10 to 21 in |
| Distribution end date | 2025-12-31 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 8888591123 | Catheter Gauge 12 Fr | In distribution | |
| 8888591024 | Catheter Gauge 14 Fr | In distribution | |
| 8888591024 | Catheter Gauge 14 Fr | In distribution | |
| 8888591040 | Catheter Gauge 18 Fr | In distribution | |
| 8888591008 | Catheter Gauge 10 Fr | In distribution | |
| 8888591123 | Catheter Gauge 12 Fr | In distribution | |
| 8888591008 | Length 10 in | In distribution | |
| 8888591040 | Length 18 in | In distribution | |
| 8888590224 | Catheter Gauge 20 Fr | Withdrawn | |
| 8888590018 | Catheter Gauge 18 Fr | Withdrawn | |
| 8888591099 | Catheter Gauge 24 Fr | Withdrawn | |
| 8888590018 | Catheter Gauge 18 Fr | Withdrawn | |
| 8888590216 | Length 18 in | Withdrawn | |
| 8888591081 | Catheter Gauge 24 Fr | Withdrawn | |
| 8888591065 | Length 20 in | Withdrawn | |
| 8888591073 | Catheter Gauge 20 Fr | Withdrawn | |
| 8888590224 | Length 20 in | Withdrawn | |
| 8888590208 | Catheter Gauge 14 Fr | Withdrawn | |
| 8888590208 | Length 20 in | Withdrawn | |
| 8888577775 | 4 | Withdrawn | |
| 8888577775 | Withdrawn | ||
| 8888591065 | Catheter Gauge 21 Fr | Withdrawn | |
| 8888591081 | Catheter Gauge 24 Fr | Withdrawn | |
| 8888591073 | Catheter Gauge 21 Fr | Withdrawn | |
| 8888591099 | Catheter Gauge 24 Fr | Withdrawn |
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
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.