Avalon Elite
7 catalogue numbers from Avalon Elite BiCaval Dual Lumen Catheter, listed by Maquet Cardiopulmonary GmbH, Germany, 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
7catalogue numbers in this listing
7510(k) clearances naming this product code
6recalls on this code
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 | Maquet Cardiopulmonary GmbH, Germany |
|---|---|
| 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, Complaint-file establishment, Manufacturer |
| 510(k) | K081820 |
| Record published | 2015-12-31 |
| Record revised | 2018-07-06 (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, manufacturing date |
| Sizes | Catheter gauge 13 to 31 Fr |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Avalon Elite BiCaval Dual Lumen Catheter | Connectors 1/4 Inch | In distribution |
| Avalon Elite BiCaval Dual Lumen Catheter | Insertion length 31 Centimeter | In distribution |
| Avalon Elite BiCaval Dual Lumen Catheter | Catheter Gauge 16 Fr | In distribution |
| Avalon Elite BiCaval Dual Lumen Catheter | Catheter Gauge 13 Fr | In distribution |
| Avalon Elite BiCaval Dual Lumen Catheter | Insertion length 31 Centimeter | In distribution |
| Avalon Elite BiCaval Dual Lumen Catheter | Connectors 3/8 Inch | In distribution |
| Avalon Elite BiCaval Dual Lumen Catheter | Connectors 3/8 Inch | 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 |
|---|---|
| K140569 | 2014-11-19 |
| K131666 | 2013-07-05 |
| K130639 | 2013-05-16 |
| K102532 | 2011-02-25 |
| K090533 | 2009-12-18 |
| K072172 | 2007-08-31 |
| K061832 | 2006-08-11 |
Recalls
3 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2026-07-31 | Not classified | Packaging | The packaging may not consistently maintain sterile barrier integrity. | 16697 units (492 USA, 16205 OUS) | |
| 2026-07-31 | Not classified | Packaging | The packaging may not consistently maintain sterile barrier integrity. | 68371 units (1765 US, 66606 OUS) | |
| 2026-07-31 | Not classified | Packaging | The packaging may not consistently maintain sterile barrier integrity. | 185617 units (5926 US, 179691 OUS) | |
| 2018-05-14 | Class II | Component design/selection | This lot of arterial cannula may have been supplied with 3/8-width de-airing plugs that could break during the process of removal from the arterial cannula. | 40 US | 2020-05-15 |
| 2018-05-14 | Class II | Component design/selection | This lot of arterial cannula may have been supplied with 3/8-width de-airing plugs that could break during the process of removal from the arterial cannula. | 470 US | 2020-05-15 |
| 2018-05-14 | Class II | Component design/selection | This lot of arterial cannula may have been supplied with 3/8-width de-airing plugs that could break during the process of removal from the arterial cannula. | 150 US | 2020-05-15 |
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.