Coracross
The coraCross Crossing Catheter provides added support to a steerable guidewire when accessing selected regions of the peripheral or coronary vasculature. Its through-lumen can carry…
The coraCross Crossing Catheter provides added support to a steerable guidewire when accessing selected regions of the peripheral or coronary vasculature. Its through-lumen can carry diagnostic contrast or saline solutions.
The filing describes a support catheter with a concealed radiopaque beveled guide tip and an activating handle. It can facilitate placement and exchange of guidewires and other interventional devices.
Listed Item
Cora Cross Coronary Crossing Catheter 14X135cm
Catheter Features
The summary describes the coraCross as a polymer catheter shaft with geometry intended to control torque and push movements during lesion crossing. The source lists component-integrity, torque and flow testing.
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 | Reflow Medical, United States |
|---|---|
| FDA product code | DQY |
| Device type | Catheter, Percutaneous |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1250 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K210188 |
| Record published | 2021-06-03 |
| Record revised | 2021-12-22 (version 2) |
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 |
| Sizes | Catheter working length 135 to 150 cm; guidewire diameter 0.014 in |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CRX14135US | Catheter Working Length 135 cm | In distribution |
| CRX14150US | Catheter Working Length 150 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K251277 | 2025-08-22 |
| K233350 | 2024-02-08 |
| K210188 | 2021-05-28 |
| K201811 | 2020-10-26 |
| K200094 | 2020-03-18 |
| K193596 | 2020-02-20 |
| K193012 | 2020-02-19 |
| K190393 | 2019-05-09 |
| K173661 | 2018-04-18 |
| K173662 | 2017-12-20 |
| K170996 | 2017-06-09 |
| K160848 | 2016-07-14 |
| K151880 | 2015-08-07 |
| K141649 | 2014-11-05 |
| K141547 | 2014-09-30 |
| K132420 | 2013-09-19 |
| K120178 | 2012-02-08 |
| K101479 | 2010-08-11 |
Recalls
1 of these is Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2017-03-22 | Class I | Under Investigation by firm | ReFlow Medical is recalling the Wingman 35 Crossing Catheter because it may be prone to tip detachment. | 2,794 units | 2017-12-06 |
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.