Racer® Biliary
Stent XD718YF Racer US Short
6manufacturers in China registered for this device type
16catalogue numbers in this listing
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 | Medtronic, 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 | Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K032768 |
| Record published | 2015-06-08 |
| Record revised | 2022-04-08 (version 5) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Storage | Special storage condition: Store at room temperature in a dark, dry place |
| Sizes | Length 12 to 18 mm |
| Distribution end date | 2019-10-21 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| XD718YF | Length 18.0 mm | Withdrawn |
| XD418YF | Nominal Stent Diameter 4 MM | Withdrawn |
| XD412YL | Length 12.0 mm | Withdrawn |
| XD618YF | Length 18.0 mm | Withdrawn |
| XD712YF | Nominal Stent Diameter 7 MM | Withdrawn |
| XD612YF | Nominal Stent Diameter 6 MM | Withdrawn |
| XD418YL | Nominal Stent Diameter 4 MM | Withdrawn |
| XD518YF | Nominal Stent Diameter 5 MM | Withdrawn |
| XD718YL | Nominal Stent Diameter 7 MM | Withdrawn |
| XD412YF | Nominal Stent Diameter 4 MM | Withdrawn |
| XD612YL | Nominal Stent Diameter 6 MM | Withdrawn |
| XD712YL | Length 12.0 mm | Withdrawn |
| XD518YL | Nominal Stent Diameter 5 MM | Withdrawn |
| XD618YL | Length 18.0 mm | Withdrawn |
| XD512YF | Length 12.0 mm | Withdrawn |
| XD512YL | Length 12.0 mm | Withdrawn |
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
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Medtronic Vascular | 510(k) number | 2009-07-30 | Not classified | Mixed-up of materials/components | Mislabeling– The incorrect Instructions for use may have been included with this product. | 13 | 2011-01-31 |
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.