Paramount Mini GPS
Balloon-Expandable Biliary Stent System
6manufacturers in China registered for this device type
18catalogue 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 | Covidien LP, 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 |
| 510(k) | K040653 |
| Record published | 2015-10-16 |
| Record revised | 2023-11-20 (version 8) |
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 |
| Storage | Special storage condition: Keep Dry |
| Sizes | Outer diameter 5 to 7 mm; length 14 to 21 mm; catheter gauge 5 to 6 Fr |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PMB4-6-18-80 | Outer Diameter 6 mm | In distribution |
| PMB4-6-21-80 | Length 21 mm | In distribution |
| PMB4-5-14-80 | Outer Diameter 5 mm | In distribution |
| PMB4-7-18-80 | Length 18 mm | In distribution |
| PMB8-6-21-80 | Outer Diameter 6 mm | In distribution |
| PMB8-5-18-80 | Outer Diameter 5 mm | In distribution |
| PMB8-6-18-80 | Catheter Gauge 5 Fr | In distribution |
| PMB4-6-14-80 | Length 14 mm | In distribution |
| PMB8-6-14-80 | Outer Diameter 6 mm | In distribution |
| PMB4-5-18-80 | Catheter Gauge 5 Fr | In distribution |
| PMB8-7-14-80 | Working Length,80,Centimeter;Compatible Guidewire,.018,Inch; | In distribution |
| PMB8-5-21-80 | Catheter Gauge 5 Fr | In distribution |
| PMB8-7-21-80 | Catheter Gauge 6 Fr | In distribution |
| PMB4-5-21-80 | Length 21 mm | In distribution |
| PMB8-5-14-80 | Outer Diameter 5 mm | In distribution |
| PMB8-7-18-80 | Length 18 mm | In distribution |
| PMB4-7-14-80 | Length 14 mm | In distribution |
| PMB4-7-21-80 | Outer Diameter 7 mm | 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
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.