CardioGard Emboli Protection Cannula
CardioGard is a double-lumen arterial cannula used during cardiopulmonary bypass. Its outlet diffuses oxygenated blood from the heart-lung machine into the ascending aorta. A separate…
CardioGard is a double-lumen arterial cannula used during cardiopulmonary bypass. Its outlet diffuses oxygenated blood from the heart-lung machine into the ascending aorta.
A separate suction inlet draws blood and particulate embolic material back toward the bypass circuit for filtration. The two lumen flows are controlled to preserve net blood delivery while adding debris removal.
Listed Item
24 Fr. (8.00 mm) Cardiopulmonary bypass cannula, arterial, for use in aorta, with suction port in tip to allow emboli removal during cardiopulmonary bypass.
Cannula and Circuit Role
The cannula combines arterial perfusion and suction within one tip configuration. It is intended for short-term bypass procedures lasting less than six hours and is supplied sterile for single use. The separate suction path returns captured material toward the heart-lung system’s filtration stage.
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 | Cardiogard Medical, Ltd., United States |
|---|---|
| FDA product code | DWF |
| Device type | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Device class | Class 2 |
| Regulation | 21 CFR 870.4210 |
| 510(k) | K182302 |
| Record published | 2022-06-01 |
| Record revised | 2024-06-19 (version 3) |
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 | Shelf box of 10, shipping box of 6 |
| Sizes | Circumference 8 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CGT2422 | Circumference 8.00 mm | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K182302 | 2019-05-17 |
| K141465 | 2015-01-09 |
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.