DxTerity™ TRA
Cath U5TRAP35SHA DXT 5F 5PK 110CM TRP35
11manufacturers in China registered for this device type
132catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (5), Guangdong (3), Zhejiang (2). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
| Amsino Medical (Kunshan) Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 53 |
| Conod Medical Shuyang Co., Ltd. | Shuyang | Jiangsu | Contract manufacturer | 22 |
| Bioxin Medical Co., Ltd. | Weihai | Shandong | Contract manufacturer | 8 |
| GRI Medical & Electronic Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 71 |
| Goals Sterilization Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 26 |
| Wuxi Goals Medical Technology Co., Ltd. | Yixing | Jiangsu | Contract manufacturer | 24 |
| Sunny Medical Device (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 11 |
| Curatia Medical Limited | Suzhou | Jiangsu | Specification developer | 5 |
| Shenzhen Vivolight Medical Device&Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 4 |
| Shenzhen Antmed Co., Ltd. | Dongguan | Guangdong | Manufacturer | 4 |
Record
| Listed by | Medtronic, Inc., United States |
|---|---|
| FDA product code | DQO |
| Device type | Catheter, Intravascular, Diagnostic |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1200 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K161287 |
| Record published | 2018-05-11 |
| Record revised | 2025-12-16 (version 4) |
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 |
| Storage | Special storage condition: Store diagnostic catheters in a cool, dry, and dark area. Do not expose diagnostic catheters to UV light. |
| Packaging | Pack of 5 |
| Sizes | Catheter gauge 5 to 6 Fr; outer diameter 1.67 to 2 mm; length 100 to 110 cm |
| Distribution end date | 2025-12-12 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| U5ULTRA35 | Catheter Gauge 5.0 Fr | In distribution |
| U6TRAN40 | Catheter Gauge 6.0 Fr | In distribution |
| U6ULTRA35SH | Catheter Gauge 6.0 Fr | In distribution |
| U6TRAN45SH | Catheter Gauge 6.0 Fr | In distribution |
| U5ULTRA40SH | Catheter Gauge 5.0 Fr | In distribution |
| U5TRAN45SHA | Catheter Gauge 5.0 Fr | In distribution |
| U6TRAN40SHA | Catheter Gauge 6.0 Fr | In distribution |
| U6TRACT | Catheter Gauge 6.0 Fr | In distribution |
| U5TRACK | Outer Diameter 1.67 mm | In distribution |
| U6TRAP45 | Length 100.0 cm | In distribution |
| U6ULTRA40SHA | Catheter Gauge 6.0 Fr | In distribution |
| U6TRACKSH | Length 100.0 cm | In distribution |
| U5TRACKSHA | Outer Diameter 1.67 mm | In distribution |
| U6ULTRA45SHA | Catheter Gauge 6.0 Fr | In distribution |
| U6TRACT | Outer Diameter 2.0 mm | In distribution |
| U6TRAN35SH | Outer Diameter 2.0 mm | In distribution |
| U5TRAP35SHA | Outer Diameter 1.67 mm | In distribution |
| U6TRAP35SH | Outer Diameter 2.0 mm | In distribution |
| U5TRACK | Catheter Gauge 5.0 Fr | In distribution |
| U6TRAN45SHA | Length 110.0 cm | In distribution |
| U5TRAN40SH | Length 100.0 cm | In distribution |
| U5TRAN35 | Length 100.0 cm | In distribution |
| U5TRACTSH | Outer Diameter 1.67 mm | In distribution |
| U6TRAN45 | Outer Diameter 2.0 mm | In distribution |
| U5TRAP45SHA | Outer Diameter 1.67 mm | In distribution |
| U6ULTRA45SH | Catheter Gauge 6.0 Fr | In distribution |
| U5ULTRA35SH | Length 100.0 cm | In distribution |
| U6TRAP45SHA | Catheter Gauge 6.0 Fr | In distribution |
| U6TRAN40SH | Length 100.0 cm | In distribution |
| U6ULTRA40 | Length 100.0 cm | In distribution |
| U6ULTRA40SH | Catheter Gauge 6.0 Fr | In distribution |
| U6TRACTSH | Catheter Gauge 6.0 Fr | In distribution |
| U5TRACKSH | Length 100.0 cm | In distribution |
| U6TRAP45SH | Outer Diameter 2.0 mm | In distribution |
| U5TRAP40SHA | Length 110.0 cm | In distribution |
| U6ULTRA40SHA | Length 110.0 cm | In distribution |
| U6TRAN35SH | Catheter Gauge 6.0 Fr | In distribution |
| U6TRACK | Outer Diameter 2.0 mm | In distribution |
| U6TRAP35 | Length 100.0 cm | In distribution |
| U6TRAP40SHA | Outer Diameter 2.0 mm | In distribution |
| U6ULTRA40 | Catheter Gauge 6.0 Fr | In distribution |
| U5ULTRA40SH | Catheter Gauge 5.0 Fr | In distribution |
| U5ULTRA35SH | Catheter Gauge 5.0 Fr | In distribution |
| U6TRACK | Outer Diameter 2.0 mm | In distribution |
| U5TRAP45SHA | Length 110.0 cm | In distribution |
| U5TRAP40SHA | Catheter Gauge 5.0 Fr | In distribution |
| U5TRAP45SH | Catheter Gauge 5.0 Fr | In distribution |
| U5TRACTSH | Catheter Gauge 5.0 Fr | In distribution |
| U5TRACKSHA | Outer Diameter 1.67 mm | In distribution |
| U5TRAN40SH | Catheter Gauge 5.0 Fr | In distribution |
| U5TRAP45 | Catheter Gauge 5.0 Fr | In distribution |
| U6ULTRA35SHA | Outer Diameter 2.0 mm | In distribution |
| U5TRACTSHA | Outer Diameter 1.67 mm | In distribution |
| U5TRAP40SH | Length 100.0 cm | In distribution |
| U6TRAN40SHA | Outer Diameter 2.0 mm | In distribution |
| U5TRAN40SHA | Length 110.0 cm | In distribution |
| U5TRACTSHA | Length 110.0 cm | In distribution |
| U5TRAP35 | Outer Diameter 1.67 mm | In distribution |
| U5ULTRA40 | Catheter Gauge 5.0 Fr | In distribution |
| U6TRAP40 | Outer Diameter 2.0 mm | In distribution |
| U6TRAP40SH | Outer Diameter 2.0 mm | In distribution |
| U6ULTRA45SHA | Catheter Gauge 6.0 Fr | In distribution |
| U6TRAP40SH | Outer Diameter 2.0 mm | In distribution |
| U5TRAP40SH | Length 100.0 cm | In distribution |
| U5ULTRA40SHA | Length 110.0 cm | In distribution |
| U6TRAN40 | Length 100.0 cm | In distribution |
| U5TRAN40SHA | Outer Diameter 1.67 mm | In distribution |
| U5ULTRA45SHA | Catheter Gauge 5.0 Fr | In distribution |
| U6TRAP35SHA | Length 110.0 cm | In distribution |
| U6ULTRA45 | Outer Diameter 2.0 mm | In distribution |
| U6ULTRA40SH | Length 100.0 cm | In distribution |
| U5TRAN35SH | Catheter Gauge 5.0 Fr | In distribution |
| U5ULTRA45 | Catheter Gauge 5.0 Fr | In distribution |
| U6ULTRA35SHA | Catheter Gauge 6.0 Fr | In distribution |
| U5ULTRA35SHA | Catheter Gauge 5.0 Fr | In distribution |
| U5ULTRA45 | Outer Diameter 1.67 mm | In distribution |
| U5TRACT | Catheter Gauge 5.0 Fr | In distribution |
| U5ULTRA35 | Catheter Gauge 5.0 Fr | In distribution |
| U5ULTRA45SH | Outer Diameter 1.67 mm | In distribution |
| U6TRAN35 | Catheter Gauge 6.0 Fr | In distribution |
| U6ULTRA35 | Catheter Gauge 6.0 Fr | In distribution |
| U6TRAP40SHA | Length 110.0 cm | In distribution |
| U5ULTRA35SHA | Catheter Gauge 5.0 Fr | In distribution |
| U5ULTRA40 | Catheter Gauge 5.0 Fr | In distribution |
| U6TRACTSHA | Catheter Gauge 6.0 Fr | In distribution |
| U6TRACKSHA | Length 110.0 cm | In distribution |
| U5TRAN40 | Length 100.0 cm | In distribution |
| U6TRAP35 | Length 100.0 cm | In distribution |
| U6TRAP40 | Outer Diameter 2.0 mm | In distribution |
| U5TRAN35 | Catheter Gauge 5.0 Fr | In distribution |
| U5TRAP45 | Length 100.0 cm | In distribution |
| U6TRAN45 | Catheter Gauge 6.0 Fr | In distribution |
| U5TRAN45 | Outer Diameter 1.67 mm | In distribution |
| U5ULTRA40SHA | Catheter Gauge 5.0 Fr | In distribution |
| U6ULTRA45SH | Catheter Gauge 6.0 Fr | In distribution |
| U5TRAP35SH | Catheter Gauge 5.0 Fr | In distribution |
| U5ULTRA45SH | Catheter Gauge 5.0 Fr | In distribution |
| U5TRACT | Outer Diameter 1.67 mm | In distribution |
| U6TRAP45 | Length 100.0 cm | In distribution |
| U5TRAP35 | Catheter Gauge 5.0 Fr | In distribution |
| U6TRAN35SHA | Catheter Gauge 6.0 Fr | In distribution |
| U5TRAN35SHA | Catheter Gauge 5.0 Fr | In distribution |
| U5TRAN40 | Catheter Gauge 5.0 Fr | In distribution |
| U5TRAN35SH | Outer Diameter 1.67 mm | In distribution |
| U5TRAP40 | Catheter Gauge 5.0 Fr | In distribution |
| U5TRAN45SH | Outer Diameter 1.67 mm | In distribution |
| U6ULTRA45 | Catheter Gauge 6.0 Fr | In distribution |
| U6TRACTSHA | Catheter Gauge 6.0 Fr | In distribution |
| U6TRAP35SHA | Length 110.0 cm | In distribution |
| U6ULTRA35 | Catheter Gauge 6.0 Fr | In distribution |
| U6ULTRA35SH | Catheter Gauge 6.0 Fr | In distribution |
| U5TRAP40 | Length 100.0 cm | In distribution |
| U6TRAN35 | Outer Diameter 2.0 mm | In distribution |
| U6TRACKSH | Length 100.0 cm | In distribution |
| U5ULTRA45SHA | Catheter Gauge 5.0 Fr | In distribution |
| U5TRAP35SHA | Outer Diameter 1.67 mm | Withdrawn |
| U5TRAN35SHA | Length 110.0 cm | Withdrawn |
| U6TRAP45SH | Length 100.0 cm | Withdrawn |
| U6TRAN35SHA | Catheter Gauge 6.0 Fr | Withdrawn |
| U6TRACTSH | Catheter Gauge 6.0 Fr | Withdrawn |
| U5TRAN45 | Catheter Gauge 5.0 Fr | Withdrawn |
| U6TRAN45SH | Outer Diameter 2.0 mm | Withdrawn |
| U5TRAN45SHA | Outer Diameter 1.67 mm | Withdrawn |
| U5TRAP45SH | Length 100.0 cm | Withdrawn |
| U6TRACKSHA | Catheter Gauge 6.0 Fr | Withdrawn |
| U5TRACKSH | Length 100.0 cm | Withdrawn |
| U6TRAN45SHA | Length 110.0 cm | Withdrawn |
| U6TRAP45SHA | Length 110.0 cm | Withdrawn |
| U6TRAN40SH | Length 100.0 cm | Withdrawn |
| U5TRAN45SH | Outer Diameter 1.67 mm | Withdrawn |
| U5TRAP35SH | Length 100.0 cm | Withdrawn |
| U6TRAP35SH | Length 100.0 cm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Performa® | Merit Medical Systems, Inc. | 1,101 |
| Impress® | Merit Medical Systems, Inc. | 839 |
| Super Torque | Cordis Corp. | 611 |
| Soft-Vu | AngioDynamics, Inc. | 591 |
| Torcon NB | Cook Incorporated | 463 |
| Mariner | AngioDynamics, Inc. | 323 |
| INT,SlideCath | Shanghai Kindly Medical Instruments Co., Ltd. | 264 |
| Infiniti | Cordis Corp. | 251 |
| Infiniti | Cordis US Corp. | 241 |
| AngiOptic | AngioDynamics, Inc. | 227 |
| Tempo | Cordis Corp. | 217 |
| SiteSeer™ | Medtronic, Inc. | 204 |
Showing 12 of 226. All products under Catheter, Intravascular, Diagnostic
Recalls Naming This Product
2 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 |
|---|---|---|---|---|---|---|---|
| Medtronic Vascular | 510(k) number | 2018-08-16 | Class III | Error in labeling | Medtronic has determined that the French size indicator on the inner pouch may incorrectly reflect a 6 French size, rather than the correct 5 French size. The catheters inside the pouch are the correct U5TRAN35 item, the outer carton has al | 250 units | 2021-05-07 |
| Medtronic Vascular | 510(k) number | 2018-03-13 | Class II | Packaging | The color coded French size indicator on the outer box may incorrectly reflect a 6 French size, rather than the correct 5 French size. The catheters inside the carton are the correct DXT5JL40 item, the inner pouch has correct 5F labeling, i | 855 units | 2021-05-07 |
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.