ReSolve®, StayFIX®
8 catalogue numbers from 00884450057520, listed by Merit Medical Systems, Inc., United States, under Stents, Drains And Dilators For The Biliary Ducts. 6 manufacturers in China are registered for this product code.
6manufacturers in China registered for this device type
8catalogue numbers in this listing
5510(k) clearances naming this product code
11recalls on this 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 | Merit Medical Systems, Inc., United States |
|---|---|
| FDA product code | FGE |
| Device type | Stents, Drains And Dilators For The Biliary Ducts |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5010 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2018-06-11 |
| Record revised | 2024-10-14 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 5 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 00884450057520 | French Size (F)-12F | In distribution |
| 00884450057841 | French Size (F)-8.5F | In distribution |
| 00884450057469 | Pigtail To Marker Band-14 cm | In distribution |
| 00884450071519 | Pigtail To Marker Band-14 cm | In distribution |
| 00884450057551 | Catheter Length (cm)-40 cm | In distribution |
| 00884450071502 | Catheter Length (cm)-40 cm | In distribution |
| 00884450057452 | French Size (F)-12F | In distribution |
| 00884450057490 | Pigtail To Marker Band-11 cm | 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 |
|---|---|
| K151925 | 2015-11-06 |
| K141408 | 2014-11-26 |
| K121832 | 2012-07-17 |
| K093947 | 2010-01-21 |
| K063733 | 2007-11-14 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2013-01-16 | Class II | Nonconforming Material/Component | A consumer complaint that a catheter was observed to be in several pieces under patient fluoroscopic visualization. | 387 units | 2015-09-16 |
| 2010-01-28 | Not classified | Component change control | Degradation of the outer portion of the delivery catheter may prevent proper deployment of the biliary stent. | 69 units | 2010-04-27 |
| 2010-01-28 | Not classified | Component change control | Degradation of the outer portion of the delivery catheter may prevent proper deployment of the biliary stent. | 16 units | 2010-04-27 |
| 2010-01-28 | Not classified | Component change control | Degradation of the outer portion of the delivery catheter may prevent proper deployment of the biliary stent. | 8 units | 2010-04-27 |
| 2010-01-28 | Not classified | Component change control | Degradation of the outer portion of the delivery catheter may prevent proper deployment of the biliary stent. | 15 units | 2010-04-27 |
| 2010-01-28 | Not classified | Component change control | Degradation of the outer portion of the delivery catheter may prevent proper deployment of the biliary stent. | 51 units | 2010-04-27 |
| 2010-01-28 | Not classified | Component change control | Degradation of the outer portion of the delivery catheter may prevent proper deployment of the biliary stent. | 6 units | 2010-04-27 |
| 2008-11-07 | Not classified | Other | Biliary drainage catheter tips may separate from the catheter shaft after placement. | 108 units | 2009-08-05 |
| 2008-11-07 | Not classified | Other | Biliary drainage catheter tips may separate from the catheter shaft after placement. | 284 units | 2009-08-05 |
| 2008-11-07 | Not classified | Other | Biliary drainage catheter tips may separate from the catheter shaft after placement. | 528 units | 2009-08-05 |
| 2008-11-07 | Not classified | Other | Biliary drainage catheter tips may separate from the catheter shaft after placement. | 244 units | 2009-08-05 |
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.