Assy,cbl,rpc,mn,shld,start,sw,udi,batch
Assy,cbl,rpc,mn,shld,start,sw,udi,batch (85594370)
15manufacturers in China registered for this device type
1catalogue number
7510(k) clearances naming this product code
17recalls on this code
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 | Bayer Medical Care Inc., United States |
|---|---|
| FDA product code | DXT |
| Device type | Injector And Syringe, Angiographic |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1650 |
| Establishment | Contract manufacturer, Remanufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K924116 |
| Record published | 2017-03-22 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| RPA 550-1 | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K252891 | 2026-02-13 |
| K192370 | 2019-12-13 |
| K193028 | 2019-12-05 |
| K182276 | 2018-11-01 |
| K182273 | 2018-11-01 |
| K173773 | 2018-08-17 |
| K143538 | 2015-08-14 |
Recalls
8 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 | Employee error | Some devices may not have been properly sterilized due to a manufacturing sterilization issue. | 27800 kits (556 boxes) | |
| 2026-04-24 | Class II | Process control | Supplier changes resulted in a fit issue with the Contrast Flow Control Valve (CFCV) interface on the Avanta Injector System. Multiple customer reports indicate that the stopcock cannot be reliably engaged with the CFCV snap interface. In i | 11,300 units (1650 US, 9650 OUS) | |
| 2021-09-14 | Class II | Packaging process control | Labeling error: MEDRAD Mark 7 Arterion Injection System Syringes (ART 700 SYR) labeled as Twist & Go Syringes (TAG 150 SYR) | 6,950 units | 2023-01-19 |
| 2020-10-05 | Class II | Process control | Specific lots of MEDRAD Stellant FLEX 150 mL syringe kits may have holes and/or cracks that have the potential to allow fluid to leak out of the syringe. | 92,420 units | 2021-03-19 |
| 2018-12-14 | Class II | Device Design | If the head mount knob is not properly tightened and the operator directly uses the injector head to move the unit, it may become disengaged, causing the injector head to become loose or fall. | 16656 | 2020-06-16 |
| 2016-08-02 | Class II | Under Investigation by firm | CertegraWorkstation when used in conjunction with the Medrad Stellant CT Injection System may exhibit thermal events, such as: smoke and sparks of fire. | 165 systems | 2016-12-09 |
| 2016-06-09 | Class II | Device Design | Bayer Healthcare is initiating this recall due to complaints that were received from customer sites describing a 4205 error message when the injector is used with a 3T scanner. | 42 units | 2016-12-05 |
| 2015-08-04 | Class II | Software design | Software Version SW 005.006_SH, resulted in the removal of purge enforcement from traditional New-Case, Power Up and Syringe Change use cases while the injector head is in the upright position. | 71 | 2016-08-17 |
| 2013-09-20 | Class II | Software design | The root cause investigation showed that the under-volume hazard can occur when the unit has been configured to prime with contrast, but instead primes with saline due to the configuration data not being sent to the injector head. This may | 133 | 2015-06-16 |
| 2011-10-24 | Not classified | Packaging | Packaging may exhibit open seals – sterility compromised | 17,380 | 2016-10-24 |
| 2011-06-02 | Not classified | Device Design | Event was initially intended to be a product enhancement of the MEDRAD Avanta Fluid Management Injection System. Upgrades were initiated in October, 2007. Observance of a possible increase in complaints and adverse event reporting resulte | 842 | 2012-06-05 |
| 2010-01-06 | Not classified | Nonconforming Material/Component | The product may be defective resulting in a reduction of the saline delivery rate and inadequate air purging. | 2625 pieces | 2010-04-08 |
| 2009-01-29 | Not classified | Packaging process control | Possible compromised sterility due to holes in styrene tray | 2958 kits | 2009-06-04 |
| 2007-10-25 | Not classified | Packaging process control | Sterility (package integrity) compromised: Incomplete package seal; sterility may be compromised | 25, 977 units | 2008-04-22 |
| 2005-10-10 | Not classified | Other | the heat maintainer, an accessory, may overheat and deform the disposable syringe | 4362 units | 2007-08-15 |
| 2004-11-03 | Not classified | Other | Sterility can be compromised by a tear in the outer packaging. | 875, 798 kits | 2005-04-20 |
| 2004-10-08 | Not classified | Other | Sterility can be compromised by a component tearing the outer packaging | 1650 kits | 2005-01-25 |
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.