Avalon Elite
Vascular Access Kit
1manufacturer
2catalogue numbers in this listing
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Lifetech Scientific (Shenzhen) Co,.ltd | Shenzhen | Guangdong | Manufacturer | 3 |
Record
| Listed by | Maquet Cardiopulmonary GmbH, Germany |
|---|---|
| FDA product code | DRE |
| Device type | Dilator, Vessel, For Percutaneous Catheterization |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1310 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K081940 |
| Record published | 2016-01-13 |
| Record revised | 2024-03-20 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Pack of 5 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| VAK | Guidewire length 100 Centimeter | In distribution |
| VAK | OD dilator 26 French | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Prelude® | Merit Medical Systems, Inc. | 323 |
| Prelude PRO™ | Merit Medical Systems, Inc. | 132 |
| Cook | Cook Incorporated | 125 |
| Avanti | Cordis Corp. | 81 |
| Dilator, Vessel, For Percutaneous Catheterization | B. Braun Interventional Systems, Inc. | 59 |
| Merit MAK™ | Merit Medical Systems, Inc. | 49 |
| Prelude ACT™ | Merit Medical Systems, Inc. | 38 |
| AngioDynamics | Navilyst Medical, Inc. | 38 |
| Super Sheath | Togo Medikit Co., Ltd. | 31 |
| Avanti | Cordis US Corp. | 29 |
| Mini Stick MAX | AngioDynamics, Inc. | 28 |
| OneStic Micro-Access Introducer | Argon Medical Devices, Inc. | 27 |
Showing 12 of 159. All products under Dilator, Vessel, For Percutaneous Catheterization
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Maquet Cardiovascular Us Sales, Llc | 510(k) number | 2020-02-20 | Class II | Under Investigation by firm | A lot of Avalon Elite Vascular Access Kits (VAK) are being recalled due to a material mix-up with the needle portion of the kit; 81 of 255 kits were assembled with an incorrect Arterial Access Needle instead of a Multi-Purpose Procedure Ne | 255 | 2022-01-18 |
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.