LF
MR Syringe (2) with Single Check Valve Y-Tubing and Filling Spikes; fits injectors: OptiStar Elite and OptiStar LE
15manufacturers in China registered for this device type
58catalogue numbers in this listing
10recalls 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 | Liebel-Flarsheim Company LLC, United States |
|---|---|
| FDA product code | DXT |
| Device type | Injector And Syringe, Angiographic |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1650 |
| Establishment | Remanufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K963071 |
| Record published | 2016-09-09 |
| Record revised | 2026-02-27 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Packaging | Case of 50, sample pack of 5, case of 20, case of 5, dispenser of 20, case of 25 |
| Sizes | Pressure 138 to 8273 KiloPascal; pressure 20 to 1200 psi; total volume 60 to 200 ml; length 76 to 229 cm; length 30 to 90 in |
| Distribution end date | 2026-06-20 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 399300 | In distribution | |
| 900008 | In distribution | |
| 814002 | In distribution | |
| 900006 | In distribution | |
| 900001 | In distribution | |
| 814004 | In distribution | |
| 814005 | In distribution | |
| 814001 | In distribution | |
| DE900001 | Withdrawn | |
| 600269P | Total Volume 150 ml | Withdrawn |
| 601277 | Pressure 2758 KiloPascal | Withdrawn |
| 844021 | Pressure 2758 KiloPascal | Withdrawn |
| DS900001 | Withdrawn | |
| 801106 | Pressure 1379 KiloPascal | Withdrawn |
| 600172 | Total Volume 130 ml | Withdrawn |
| 844022 | Pressure 2758 KiloPascal | Withdrawn |
| DL802001 | Withdrawn | |
| 601281 | Pressure 6895 KiloPascal | Withdrawn |
| 601195 | Length 152 cm | Withdrawn |
| 900103P | Total Volume 150 ml | Withdrawn |
| DE814001 | Withdrawn | |
| 814001C | Withdrawn | |
| 900003 | Withdrawn | |
| 814004C | Withdrawn | |
| DL900006 | Withdrawn | |
| 800096 | Total Volume 200 ml | Withdrawn |
| 810555 | Pressure 2413 KiloPascal | Withdrawn |
| 800099 | Pressure 2758 KiloPascal | Withdrawn |
| DS900006 | Withdrawn | |
| 801801 | Total Volume 60 ml | Withdrawn |
| 900001C | Withdrawn | |
| DL814001 | Withdrawn | |
| 844011 | Pressure 2758 KiloPascal | Withdrawn |
| DL844001 | Withdrawn | |
| 900105P | Total Volume 200 ml | Withdrawn |
| DL900001 | Withdrawn | |
| 814005C | Withdrawn | |
| 844012 | Pressure 2758 KiloPascal | Withdrawn |
| 800099P | Pressure 2758 KiloPascal | Withdrawn |
| 900103 | Total Volume 150 ml | Withdrawn |
| 900006C | Withdrawn | |
| 600269 | Total Volume 150 ml | Withdrawn |
| 844023 | Pressure 2758 KiloPascal | Withdrawn |
| 801800 | Pressure 1379 KiloPascal | Withdrawn |
| 810551 | Pressure 138 KiloPascal | Withdrawn |
| 900105 | Total Volume 200 ml | Withdrawn |
| 302050 | Withdrawn | |
| 601280 | Pressure 6895 KiloPascal | Withdrawn |
| 844010 | Pressure 2758 KiloPascal | Withdrawn |
| 844022P | Total Volume 200 ml | Withdrawn |
| DS814001 | Withdrawn | |
| 801107 | Length 90 in | Withdrawn |
| 900002 | Withdrawn | |
| 900101 | Total Volume 150 ml | Withdrawn |
| 844023P | Total Volume 200 ml | Withdrawn |
| 800096P | Total Volume 200 ml | Withdrawn |
| 844021P | Total Volume 200 ml | Withdrawn |
| 814002C | Withdrawn |
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 |
| 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 |
| CVi® Cable | Acist Medical Systems, Inc. | 30 |
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 |
|---|---|---|---|---|---|---|---|
| Liebel-Flarsheim Company LLC | 510(k) number | 2012-02-10 | Not classified | Packaging process control | The machine used to package the product was missing a tool, which could prevent the packaging from sealing properly, causing the sterility of the product to be compromised. | 665 Cases | 2013-12-24 |
| Liebel-Flarsheim Company LLC | 510(k) number | 2012-02-10 | Not classified | Packaging process control | The machine used to package the product was missing a tool, which could prevent the packaging from sealing properly, causing the sterility of the product to be compromised. | 2013-12-24 | |
| Liebel-Flarsheim Company LLC | 510(k) number | 2012-02-10 | Not classified | Packaging process control | The machine used to package the product was missing a tool, which could prevent the packaging from sealing properly, causing the sterility of the product to be compromised. | 2013-12-24 | |
| Liebel-Flarsheim Company LLC | 510(k) number | 2012-02-10 | Not classified | Packaging process control | The machine used to package the product was missing a tool, which could prevent the packaging from sealing properly, causing the sterility of the product to be compromised. | 2013-12-24 | |
| Liebel-Flarsheim Company LLC | 510(k) number | 2012-02-10 | Not classified | Packaging process control | The machine used to package the product was missing a tool, which could prevent the packaging from sealing properly, causing the sterility of the product to be compromised. | 2013-12-24 | |
| Liebel-Flarsheim Company LLC | 510(k) number | 2012-02-10 | Not classified | Packaging process control | The machine used to package the product was missing a tool, which could prevent the packaging from sealing properly, causing the sterility of the product to be compromised. | 2013-12-24 | |
| Liebel-Flarsheim Company LLC | 510(k) number | 2011-12-20 | Not classified | Packaging | The firm received complaints from their customers stating that they found open seals on two of their sterilized products. | 63,900 units | 2013-02-19 |
| Liebel-Flarsheim Company LLC | 510(k) number | 2010-02-01 | Class II | Packaging process control | A report was received from a Japanese distributor regarding a complaint from a hospital customer stating that ten packages of Handi Fil were not sealed. | 75 cases (100 units per case) | 2012-08-03 |
| Liebel-Flarsheim Company LLC | 510(k) number | 2007-08-24 | Not classified | Device Design | Synchronization problems: units that have both a main programmable console and an auxiliary programmable console, when simultaneously, injection parameters are programmed into the unit’s main console and the unit’s auxiliary consoles, mis-s | 176 | 2010-08-17 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2008-04-14 | Not classified | Device Design | The tubing metal begins to crack and thin. When this occurs it causes the tubing material to crack around the screws. This can cause the tubing to fall from the mounting plug. | 2546 pieces | 2011-05-20 |
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.