enableCV EZ Glide™ Aortic Cannula
enableCV EZ Glide™ Aortic Cannula - EZF24TA
3manufacturers in China registered for this device type
10catalogue 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 | Enablecv, 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 | Specification developer, Manufacturer |
| 510(k) | K123370 |
| Record published | 2026-02-14 |
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, manufacturing date |
| Storage | Special storage condition: Store sterile packaged device in a cool, dry place. |
| Packaging | Pack of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| EZC24A | 24 Fr. (8.0 mm) X 37.6 cm (14.8″) | In distribution |
| EZF24TA | 24 Fr. (8.0 mm) X 37.6 cm (14.8″) | In distribution |
| EZS21TA | 21 Fr. (7.0 mm) X 35 cm (14″) | In distribution |
| EZF21TA | 21 Fr. (7.0 mm) X 37.6 cm (14.8″) | In distribution |
| EZF24A | 24 Fr. (8.0 mm) X 37.6 cm (14.8″) | In distribution |
| EZS24A | 24 Fr. (8.0 mm) X 35 cm (14″) | In distribution |
| EZS21A | 21 Fr. (7.0 mm) X 35 cm (14″) | In distribution |
| EZS24TA | 24 Fr. (8.0 mm) X 35 cm (14″) | In distribution |
| EZF21A | 21 Fr. (7.0 mm) X 37.6 cm (14.8″) | In distribution |
| EZC24TA | 24 Fr. (8.0 mm) X 37.6 cm (14.8″) | 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 |
|---|---|---|---|---|---|---|---|
| Edwards Lifesciences Technology Sarl | 510(k) number | 2019-10-22 | Class II | Under Investigation by firm | Their is a possibility that the cannula may separate from its connector, potentially causing a breach of circuit during cardiopulmonary bypass which could result in significant blood loss. | 62,431 units | 2022-06-29 |
| SPS Sterilization, Inc | 510(k) number | 2018-03-07 | Class II | Labeling False and Misleading | The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life. | 10 units total | 2018-11-27 |
| SPS Sterilization, Inc | 510(k) number | 2018-03-07 | Class II | Labeling False and Misleading | The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life. | 6 units total | 2018-11-27 |
| Edwards Lifesciences Technology Sarl | 510(k) number | 2013-08-26 | Class II | Process control | Edwards Lifesciences is recalling two lots of Duraflo Cannulas due to reported complaints involving cracks in the t-connector of the devices which were confirmed during product evaluation. | 80 units | 2017-02-22 |
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.