Argyle
Argyle Left Ventricular Sump Vent Catheter, Catheter Retention Ring, 18 Fr/Ch (6.0 mm) x 20 in. (51 cm)
3manufacturers in China registered for this device type
13catalogue 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 200, LLC, 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, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2025-01-28 |
| Record revised | 2025-12-31 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 10 |
| Sizes | Catheter gauge 14 to 24 Fr; length 8 to 20 in |
| Distribution end date | 2025-12-31 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 8888577775 | In distribution | ||
| 8888590208 | Length 20 in | In distribution | |
| 8888590224 | Length 20 in | In distribution | |
| 5558590203 | Catheter Gauge 14 Fr | 20 | In distribution |
| 8888591099 | Length 8 in | In distribution | |
| 8888591065 | Catheter Gauge 21 Fr | In distribution | |
| 8888591073 | Length 8 in | In distribution | |
| 8888591081 | Length 8 in | In distribution | |
| 8888590216 | Length 20 in | In distribution | |
| 8888590018 | Length 20 in | In distribution | |
| 8888590208 | Withdrawn | ||
| 8888590216 | Withdrawn | ||
| 8888590224 | Withdrawn |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.