Wallstent
WALLSTENT SS guidewire .035" B/5
21manufacturers in China registered for this device type
1catalogue number
4510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (8), Zhejiang (7), Guangdong (3). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Changzhou Jiuhong Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 10 |
| Micro-Tech (Nanjing) Co., Ltd. | Nan Jing | Jiangsu | Contract manufacturer | 49 |
| Well Lead Medical Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 46 |
| Beijing Zksk Technology Co., Ltd. | Beijing | Beijing | Contract manufacturer | 38 |
| Zhejiang Chuangxiang Medical Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 27 |
| Yangzhou Fartley Medical Instrument Technology Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 24 |
| Jiana Sterilization Technology (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 23 |
| Shenzhen Hugemed Medical Technical Development Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 22 |
| Jiangsu Vedkang Medical Science and Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 20 |
| Alton Shanghai Medical Instruments Co Ltd | Shanghai | Shanghai | Complaint-file establishment | 20 |
| Hangzhou AGS MedTech Co., Ltd. | Hangzhou | Zhejiang | Repacker / relabeller | 19 |
| Scivita Medical Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 19 |
Showing 12 of 21. All 21 manufacturers in China registered for Endoscopic Guidewire, Gastroenterology-Urology
Record
| Listed by | Lake Region Medical Limited, Ireland |
|---|---|
| FDA product code | OCY |
| Device type | Endoscopic Guidewire, Gastroenterology-Urology |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Record published | 2016-11-06 |
| Record revised | 2018-03-29 (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, manufacturing date |
| Packaging | Pack of 5 |
| Sizes | Outer diameter 0.035 in |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| H965180011 | Outer Diameter 0.035 in | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Single Use Urinary Guidewire | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 332 |
| Single Use Guidewire | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 194 |
| Roadrunner | Cook Incorporated | 44 |
| Cook | Cook Incorporated | 43 |
| Jagwire | Boston Scientific Corporation | 35 |
| Ercp | Heraeus Medical Components, SRL | 32 |
| Hydrophilic Guidewire for Urinary Tract | Shenzhen Hainwise Medical Technology Co., Ltd. | 24 |
| Acrobat | Cook Incorporated | 20 |
| Amplatz | Cook Incorporated | 19 |
| RevoWave™ | Piolax Medical Devices, Inc. | 19 |
| Zksk | Beijing Zksk Technology Co., Ltd. | 18 |
| Tracer Metro | Cook Incorporated | 17 |
Showing 12 of 60. All products under Endoscopic Guidewire, Gastroenterology-Urology
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K142397 | 2014-09-19 |
| K140482 | 2014-04-08 |
| K124052 | 2013-02-26 |
| K080508 | 2008-03-21 |
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.