Zilver 635
Zilver 635 Biliary Stent, Expandable Metal Biliary Stent System
6manufacturers in China registered for this device type
55catalogue numbers in this listing
11510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (3), Zhejiang (2), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Micro-Tech (Nanjing) Co., Ltd. | Nan Jing | Jiangsu | Contract manufacturer | 49 |
| Zhejiang Chuangxiang Medical Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 27 |
| Jiangsu Vedkang Medical Science and Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 20 |
| Hangzhou AGS MedTech Co., Ltd. | Hangzhou | Zhejiang | Repacker / relabeller | 19 |
| Dongguan TT Medical, Inc. | Dongguan | Guangdong | Manufacturer | 4 |
| LEO Medical Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 4 |
Record
| Listed by | Cook Ireland Ltd, Ireland |
|---|---|
| FDA product code | FGE |
| Device type | Stents, Drains And Dilators For The Biliary Ducts |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5010 |
| Establishment | Complaint-file establishment, Manufacturer |
| Record published | 2019-04-10 |
| Record revised | 2022-04-08 (version 4) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Store in dark, dry, cool place. Avoid extended exposure to light.; Storage environment temperature 2 to 40 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| G31495 | In distribution | |
| G36009 | In distribution | |
| G32005 | In distribution | |
| G50617 | In distribution | |
| G36231 | In distribution | |
| G32008 | In distribution | |
| G36246 | In distribution | |
| G36233 | In distribution | |
| G23812 | In distribution | |
| G50621 | In distribution | |
| G31486 | In distribution | |
| G50620 | In distribution | |
| G32007 | In distribution | |
| G36022 | In distribution | |
| G36229 | In distribution | |
| G32001 | In distribution | |
| G50624 | In distribution | |
| G36236 | In distribution | |
| G50619 | In distribution | |
| G36239 | In distribution | |
| G36241 | In distribution | |
| G53403 | In distribution | |
| G36011 | In distribution | |
| G23816 | In distribution | |
| G36244 | In distribution | |
| G53402 | In distribution | |
| G36021 | In distribution | |
| G32009 | In distribution | |
| G53404 | In distribution | |
| G50622 | In distribution | |
| G36243 | In distribution | |
| G36230 | In distribution | |
| G31494 | In distribution | |
| G32033 | In distribution | |
| G36240 | In distribution | |
| G31487 | In distribution | |
| G32032 | In distribution | |
| G23814 | In distribution | |
| G36234 | In distribution | |
| G32030 | In distribution | |
| G50618 | In distribution | |
| G36245 | In distribution | |
| G23813 | In distribution | |
| G36235 | In distribution | |
| G36228 | In distribution | |
| G36015 | In distribution | |
| G50616 | In distribution | |
| G36238 | In distribution | |
| G50623 | In distribution | |
| G32006 | In distribution | |
| G32031 | In distribution | |
| G36013 | In distribution | |
| G23815 | In distribution | |
| G36014 | In distribution | |
| G23811 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Zimmon | Cook Ireland Ltd | 213 |
| Single Use Biliary Drainage Stent V | Olympus Medical Systems Corp. | 181 |
| Mustang™ | Boston Scientific Corporation | 167 |
| Geenen | Cook Ireland Ltd | 158 |
| Cotton-Leung | Cook Ireland Ltd | 144 |
| Advanix™ Pancreatic Stent | Boston Scientific Corporation | 135 |
| Single Use Biliary Stent V | Olympus Medical Systems Corp. | 106 |
| Single-use Balloon Dilatation Catheter | LEO Medical Co., Ltd. | 102 |
| Biliary Plastic Stent Set | Micro-Tech (Nanjing) Co., Ltd. | 90 |
| Biliary Plastic Stent | Micro-Tech (Nanjing) Co., Ltd. | 90 |
| M-Drain | Mermaid Medical A/S | 86 |
| Advanix™ Biliary | Boston Scientific Corporation | 84 |
Showing 12 of 212. All products under Stents, Drains And Dilators For The Biliary Ducts
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K233079 | 2024-06-14 |
| K213946 | 2022-05-09 |
| K182980 | 2018-11-16 |
| K180868 | 2018-07-06 |
| K172057 | 2018-03-09 |
| K172044 | 2018-02-27 |
| K171623 | 2017-07-31 |
| K163169 | 2017-02-07 |
| K163018 | 2016-12-23 |
| K121430 | 2013-03-01 |
| K060624 | 2006-08-04 |
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.