Kyphon® Inflation Syringe
Syringe A08A Kyphx Xpander Inflation
15manufacturers in China registered for this device type
3catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (7), Jiangsu (3), Shandong (2). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Changzhou DSB Medical Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 16 |
| Hangzhou Jincheng Medical Supplies Manufacture Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 15 |
| Sunny Medical Device (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 11 |
| ShanDong WeiGao Group Medical Polymer Co., Ltd. | Weihai | Shandong | Contract manufacturer | 3 |
| Jiangxi Baoeran Biomedical Science & Technology Co., Ltd. | Fuzhou | Jiangxi | Contract manufacturer | 1 |
| Suzhou Meccan Import and Export Corp. | Suzhou | Jiangsu | Contract manufacturer | 71 |
| Sterigenics Shanghai ETO Ltd. | Shanghai | Shanghai | Contract manufacturer | 65 |
| Vincent Medical (Dong Guan) Manufacturing Co., Ltd. | Dong Guan | Guangdong | Contract manufacturer | 29 |
| Wuxi Yushou Medical Appliances Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 8 |
| Shandong INT Medical Instruments Co., Ltd. | Rizhao | Shandong | Manufacturer | 4 |
| Zhuhai DR Medical Instruments Co., Ltd. | Zhuhai | Guangdong | Manufacturer | 4 |
| Shenzhen Antmed Co., Ltd. | Dongguan | Guangdong | Manufacturer | 4 |
Showing 12 of 15. All 15 manufacturers in China registered for Injector And Syringe, Angiographic
Record
| Listed by | Medtronic Sofamor Danek, Inc., United States |
|---|---|
| FDA product code | DXT |
| Device type | Injector And Syringe, Angiographic |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1650 |
| 510(k) | K011811 |
| Record published | 2016-04-02 |
| Record revised | 2020-05-06 (version 5) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| A08A | In distribution | |
| A08A | In distribution | |
| A08A | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sinton Medical Products | Shenzhen Boon Medical Supply Co., Ltd. | 199 |
| DeRoyal | Deroyal Industries, Inc. | 138 |
| Antmed | Shenzhen Antmed Co., Ltd. | 91 |
| Medline Industries, Inc. | Medline Industries, Inc. | 59 |
| LF | Liebel-Flarsheim Company LLC | 58 |
| Namic | Medline Industries, Inc. | 50 |
| Merit Medical® | Merit Medical Systems, Inc. | 46 |
| Medical Imaging Solutions International | Shenzhen Boon Medical Supply Co., Ltd. | 43 |
| LF | Shenzhen Boon Medical Supply Co., Ltd. | 38 |
| Namic | Navilyst Medical, Inc. | 38 |
| Coeur | Coeur, Inc. | 38 |
| Medical Imaging Solutions Intl. | Medical Imaging Solutions, Inc. | 37 |
Showing 12 of 168. All products under Injector And Syringe, Angiographic
Recalls Naming This Product
9 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 |
|---|---|---|---|---|---|---|---|
| Merit Medical Systems, Inc. | 510(k) number | 2024-08-30 | Class II | Nonconforming Material/Component | Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier. | 110,650 devices | |
| Merit Medical Systems, Inc. | 510(k) number | 2024-08-30 | Class II | Nonconforming Material/Component | Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier. | 41,411 devices | |
| Merit Medical Systems, Inc. | 510(k) number | 2024-08-30 | Class II | Nonconforming Material/Component | Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier. | 1,120 devices | |
| Merit Medical Systems, Inc. | 510(k) number | 2024-08-30 | Class II | Nonconforming Material/Component | Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier. | 6,565 devices | |
| Merit Medical Systems, Inc. | 510(k) number | 2024-08-30 | Class II | Nonconforming Material/Component | Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier. | 51,900 devices | |
| Merit Medical Systems, Inc. | 510(k) number | 2024-08-30 | Class II | Nonconforming Material/Component | Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier. | 432 devices | |
| Merit Medical Systems, Inc. | 510(k) number | 2024-08-19 | Class II | Packaging process control | Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection. | 12,910 | |
| Covidien | 510(k) number | 2003-10-13 | Not classified | Other | Devices for which sterility may be compromised as evidenced by a loss of package integrity. | 211 syringes | 2004-03-08 |
| Merit Medical Systems, Inc. | 510(k) number | 2003-10-01 | Not classified | Other | There is a potential for the PETG blister trays to bond together with varying degrees of attachment. The potential for non-sterility exists when the attached trays are seperated by force and holes or cracks are generated in the seperated t | 1997 units | 2004-02-02 |
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.