Britecross™ Support Catheter
BriteCross is a flexible single-lumen support catheter for peripheral vascular access. It guides and supports a guidewire, permits wire exchange and delivers saline or diagnostic contrast.…
BriteCross is a flexible single-lumen support catheter for peripheral vascular access. It guides and supports a guidewire, permits wire exchange and delivers saline or diagnostic contrast. The catheter advances over a wire through a guide catheter or introducer sheath under fluoroscopy.
A radiopaque distal tip assists positioning, while two shaft marker bands provide a reference for estimating lesion length. The proximal hub has a female Luer connection and integrated strain relief. Catheter size is printed on the hub.
Listed Item
BriteCross.035 x 135CM
Configurations and Supply
The range includes different lengths and diameters and is supplied sterile for single use. The catheter can navigate to a target peripheral lesion and serve as a conduit while the guidewire is exchanged. It provides support and fluid access rather than performing balloon dilation or plaque removal.
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 | Cordis US Corp., 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, Exporter |
| 510(k) | K233637 |
| Record published | 2025-09-01 |
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, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| BC35900 | In distribution | |
| BC14650 | In distribution | |
| BC18650 | In distribution | |
| BC35135 | In distribution | |
| BC18900 | In distribution | |
| BC18200 | In distribution | |
| BC14200 | In distribution | |
| BC14900 | In distribution | |
| BC35190 | In distribution | |
| BC14150 | In distribution | |
| BC18150 | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K233637 | 2024-06-28 |
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2025-02-07 | Class II | Employee error | Catheter manufactured at the incorrect length. | 12 units | |
| 2019-02-07 | Class III | Equipment maintenance | Frayed pieces of the mounting card being inside the primary packaging. | 23481 | 2021-11-03 |
| 2013-08-12 | Class II | Error in labeling | Due to a labeling error related to the conversion of the inner diameter of the catheter from inches to millimeters. The English dimension is correct and is the primary dimension. | 1238 units | 2014-09-30 |
| 2004-12-07 | Not classified | Other | Two complaints have been received and confirmed, regarding a lot, indicating that the distal end had an ‘RDC’ shape rather than the ‘RDC(1)’ shape. The RDC shape has a larger curve. The product was manufactured with the incorrect forming w | 153 units | 2008-11-19 |
| 2004-05-05 | Not classified | Other | The product is labeled as Straight Catheter but the package contains Contralateral Guide shaped Catheters. | 40 | 2008-11-21 |
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.