Supercross
SuperCross 014 AT, 90 Degree XT, 150cm
14manufacturers in China registered for this device type
30catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (5), Jiangsu (5), Guangdong (3). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jabil Circuit (Shanghai) Ltd. | Shanghai | Shanghai | Contract manufacturer | 31 |
| Covidien Medical Products (Shanghai) Manufacturing LLC | Shanghai | Shanghai | Contract manufacturer | 8 |
| Sterigenics Shanghai ETO Ltd. | Shanghai | Shanghai | Contract manufacturer | 65 |
| Steris Sterilization Technologies (Suzhou) Ltd | Suzhou | Jiangsu | Contract manufacturer | 44 |
| Goals Sterilization Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 26 |
| Wuxi Goals Medical Technology Co., Ltd. | Yixing | Jiangsu | Contract manufacturer | 24 |
| Suzhou Zenith Vascular Scitech Limited | Suzhou | Jiangsu | Manufacturer | 6 |
| Haolang Technology (Foshan) Limited Corporation | Foshan | Guangdong | Contract manufacturer | 6 |
| OrbusNeich Medical (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Complaint-file establishment | 5 |
| Curatia Medical Limited | Suzhou | Jiangsu | Specification developer | 5 |
| Shanghai Wallaby Medical Technologies Co., Inc. | Shanghai | Shanghai | Contract manufacturer | 5 |
| DK Medical Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 3 |
Showing 12 of 14. All 14 manufacturers in China registered for Catheter, Percutaneous
Record
| Listed by | Teleflex Medical LLC, United States |
|---|---|
| FDA product code | DQY |
| Device type | Catheter, Percutaneous |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1250 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K210647 |
| Record published | 2026-03-23 |
| Record revised | 2022-06-10 (version 4) |
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 |
| Packaging | Box, case of 50 |
| Sizes | Length 130 to 150 cm; angle 45 to 120 °; catheter gauge 1.8 Fr |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5303 | Length 150.0 cm | In distribution |
| 5302 | Length 130.0 cm | In distribution |
| IPN913557 | Length 150 cm | In distribution |
| IPN913555 | Length 130 cm | In distribution |
| IPN913552 | Angle 120 ° | In distribution |
| IPN916131 | Length 150 cm | In distribution |
| IPN913545 | Length 130 cm | In distribution |
| IPN916126 | Length 130 cm | In distribution |
| IPN913550 | Angle 90 ° | In distribution |
| IPN916128 | Length 130 cm | In distribution |
| 5307 | Length 150.0 cm | In distribution |
| IPN916127 | Length 150 cm | In distribution |
| 5309 | Length 150.0 cm | In distribution |
| IPN913554 | Angle 90 ° | In distribution |
| 5308 | Length 130.0 cm | In distribution |
| IPN930492 | In distribution | |
| IPN930493 | In distribution | |
| IPN916130 | Length 130 cm | In distribution |
| IPN913551 | Length 130 cm | In distribution |
| 5304 | Length 130.0 cm | In distribution |
| IPN916125 | Length 150 cm | In distribution |
| IPN913549 | Length 130 cm | In distribution |
| 5306 | Length 130.0 cm | In distribution |
| IPN913547 | Length 130 cm | In distribution |
| IPN913553 | Angle 90 ° | In distribution |
| IPN916124 | Length 130 cm | In distribution |
| IPN913546 | Length 150 cm | In distribution |
| IPN916129 | Length 150 cm | In distribution |
| IPN913548 | Angle 45 ° | In distribution |
| 5305 | Length 150.0 cm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Launcher™ | Medtronic, Inc. | 3,805 |
| Sherpa NX Balanced™ | Medtronic, Inc. | 1,523 |
| Arrow | Teleflex Medical LLC | 1,249 |
| Z2 | Medtronic, Inc. | 955 |
| Vista Brite TIP | Cordis Corp. | 789 |
| Mach1™ | Boston Scientific Corporation | 777 |
| Sherpa NX Active | Medtronic, Inc. | 571 |
| Zuma® | Medtronic, Inc. | 569 |
| Convey | Pendracare International B.V. | 532 |
| Taiga | Medtronic, Inc. | 307 |
| RunWay™ | Boston Scientific Corporation | 300 |
| ConcierGE Guiding Excellence™ | Merit Medical Systems, Inc. | 295 |
Showing 12 of 500. All products under Catheter, Percutaneous
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 |
|---|---|---|---|---|---|---|---|
| Vascular Solutions LLC | 510(k) number | 2013-01-29 | Class II | Material/Component Contamination | Vascular Solutions, Inc has discovered a potential problem with a number of lots of Supercross microcatheters. A potential for surface contamination on aged catheters was observed during in-house testing. | 4731 | 2013-06-25 |
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.