Jagwire
High Performance Extendable Guidewire
21manufacturers in China registered for this device type
35catalogue numbers in this listing
5510(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 | Boston Scientific Corporation, United States |
|---|---|
| FDA product code | OCY |
| Device type | Endoscopic Guidewire, Gastroenterology-Urology |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-09-24 |
| Record revised | 2024-12-23 (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, expiry date |
| Packaging | Pack of 2 |
| Distribution end date | 2024-03-20 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| M00556870 | 0.035 in Diameter | In distribution |
| M00556660 | 0.035 in Diameter | In distribution |
| M00556610 | 450 cm Length | In distribution |
| M00556650 | 260 cm Length | In distribution |
| M00556620 | 0.038 in Diameter | In distribution |
| M00557640 | 0.035 in Diameter | In distribution |
| M00556490 | 0.025 in Diameter | In distribution |
| M00556590 | 450 cm Length | In distribution |
| M00557660 | 0.035 in Diameter | In distribution |
| M00556510 | 0.025 in Diameter | In distribution |
| M00556560 | 450 cm Length | In distribution |
| M00556480 | 0.025 in Diameter | In distribution |
| M00557670 | 0.035 in Diameter | In distribution |
| M00556640 | 0.035 in Diameter | In distribution |
| M00556600 | 0.035 in Diameter | In distribution |
| M00556580 | 0.035 in Diameter | In distribution |
| M00557650 | 0.035 in Diameter | In distribution |
| M00556460 | 260 cm Length | In distribution |
| M00556630 | 0.035 in Diameter | In distribution |
| M00556520 | 0.025 in Diameter | In distribution |
| M00556840 | 0.035 in Diameter | In distribution |
| M00556860 | 260 cm Length | In distribution |
| M00556850 | 260 cm Length | In distribution |
| M00556530 | 450 cm Length | In distribution |
| M0055660010 | 0.035 in Diameter | Withdrawn |
| M0055658010 | 450 cm Length | Withdrawn |
| M0055662010 | 0.038 in Diameter | Withdrawn |
| M0055661010 | 0.035 in Diameter | Withdrawn |
| M00556930 | 260 cm Length | Withdrawn |
| M0055656010 | 450 cm Length | Withdrawn |
| M0055659010 | 450 cm Length | Withdrawn |
| M00556920 | 0.035 in Diameter | Withdrawn |
| M00556940 | 0.035 in Diameter | Withdrawn |
| M00556950 | 0.035 in Diameter | Withdrawn |
| M00557680 | 0.025 in Diameter | Withdrawn |
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 |
| 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 |
| VISIGLIDE2 | Terumo Corp. | 16 |
Showing 12 of 60. All products under Endoscopic Guidewire, Gastroenterology-Urology
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K141820 | 2014-10-21 |
| K944959 | 1994-11-04 |
| K943737 | 1994-08-17 |
| K931650 | 1993-06-25 |
| K892648 | 1989-05-24 |
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.