Dornier MedTech
Cascade Ureteral Stent, 4.9Fr x 22-32cm Variable
4manufacturers in China registered for this device type
25catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Shanghai (2), Zhejiang (1), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Chuangxiang Medical Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 27 |
| Alton Shanghai Medical Instruments Co Ltd | Shanghai | Shanghai | Complaint-file establishment | 20 |
| BQ Plus Medical Co., Ltd. | Songjiang | Shanghai | Contract manufacturer | 13 |
| Shenzhen Trious Medical Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 6 |
Record
| Listed by | Dornier Medtech America, Inc., United States |
|---|---|
| FDA product code | FAD |
| Device type | Stent, Ureteral |
| Device class | Class 2 |
| Regulation | 21 CFR 876.4620 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2020-02-24 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Cascade Ureteral Stent, 6Fr x 22-32cm Variable | In distribution | |
| Cascade Ureteral Stent, 7Fr x 24cm | In distribution | |
| Cascade Ureteral Stent, 8Fr x 26cm | In distribution | |
| Cascade Ureteral Stent, 7Fr x 22-32cm Variable | In distribution | |
| Cascade Ureteral Stent, 6Fr x 20cm | In distribution | |
| Cascade Ureteral Stent, 4.9Fr x 26cm | In distribution | |
| Cascade Ureteral Stent, 4.9Fr x 22cm | In distribution | |
| Cascade Ureteral Stent, 4.9Fr x 14cm | In distribution | |
| Cascade Ureteral Stent, 8Fr x 22cm | In distribution | |
| Cascade Ureteral Stent, 4.9Fr x 28cm | In distribution | |
| Cascade Ureteral Stent, 7Fr x 28cm | In distribution | |
| Cascade Ureteral Stent, 7Fr x 26cm | In distribution | |
| Cascade Ureteral Stent, 4.9Fr x 24cm | In distribution | |
| Cascade Ureteral Stent, 6Fr x 26cm | In distribution | |
| Cascade Ureteral Stent, 6Fr x 28cm | In distribution | |
| Cascade Ureteral Stent, 7Fr x 20cm | In distribution | |
| Cascade Ureteral Stent, 8Fr x 20cm | In distribution | |
| Cascade Ureteral Stent, 7Fr x 22cm | In distribution | |
| Cascade Ureteral Stent, 6Fr x 22cm | In distribution | |
| Cascade Ureteral Stent, 4.9Fr x 20cm | In distribution | |
| Cascade Ureteral Stent, 8Fr x 22-32cm Variable | In distribution | |
| Cascade Ureteral Stent, 8Fr x 28cm | In distribution | |
| Cascade Ureteral Stent, 8Fr x 24cm | In distribution | |
| Cascade Ureteral Stent, 4.9Fr x 22-32cm Variable | In distribution | |
| Cascade Ureteral Stent, 6Fr x 24cm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Porges Coloplast | Coloplast A/S | 509 |
| Polaris™ Ultra | Boston Scientific Corporation | 406 |
| Universa | Cook Incorporated | 384 |
| Percuflex™ Plus | Boston Scientific Corporation | 300 |
| Polaris™ Loop | Boston Scientific Corporation | 232 |
| ImaJin | Coloplast A/S | 219 |
| Contour™ | Boston Scientific Corporation | 205 |
| Percuflex™ | Boston Scientific Corporation | 152 |
| Tecoflex | Gyrus Acmi, Inc. | 92 |
| Vortek | Coloplast A/S | 92 |
| Sof-Flex | Cook Incorporated | 60 |
| Tria™ Firm | Boston Scientific Corporation | 58 |
Showing 12 of 131. All products under Stent, Ureteral
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K190312 | 2019-11-15 |
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.