Visi-Pro™
Balloon-Expandable Biliary Stent System
6manufacturers in China registered for this device type
81catalogue 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) | P030045 |
| Record published | 2018-09-09 |
| Record revised | 2024-02-15 (version 7) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Keep dry; Special storage condition: Keep away from sunlight |
| Sizes | Outer diameter 2.2 to 10 mm; length 12 to 57 mm; catheter gauge 6 to 7 Fr |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PXB35-09-37-135 | Length 37.0 mm | In distribution |
| PXB35-08-27-135 | Catheter Gauge 6 Fr | In distribution |
| PXB35-05-37-080 | Max. Guidewire.89 MM | In distribution |
| PXB35-10-57-135 | Catheter Gauge 7 Fr | In distribution |
| PXB35-06-27-135 | Catheter Gauge 6.0 Fr | In distribution |
| PXB35-06-37-135 | Length 37 mm | In distribution |
| PXB35-08-37-080 | Length 37 mm | In distribution |
| PXB35-07-37-080 | Outer Diameter 7.0 mm | In distribution |
| PXB35-09-37-080 | Length 37.0 mm | In distribution |
| PXB35-10-17-135 | Outer Diameter 10 mm | In distribution |
| PXB35-06-17-135 | Catheter Gauge 6 Fr | In distribution |
| PXB35-10-57-135 | Max. Guidewire.89 MM | In distribution |
| PXB35-08-57-080 | Length 57 mm | In distribution |
| PXB35-08-37-080 | Outer Diameter 8.0 mm | In distribution |
| PXB35-05-27-080 | Outer Diameter 5 mm | In distribution |
| PXB35-07-27-080 | Working Length,80,Centimeter;Compatible Guidewire,.035,Inch;Rated Burst Pressure,12,AT;Nominal Pressure,10,AT; | In distribution |
| PXB35-06-37-080 | Catheter Gauge 6 Fr | In distribution |
| PXB35-06-57-135 | Length 57 mm | In distribution |
| PXB35-06-12-080 | Catheter Gauge 6 Fr | In distribution |
| PXB35-07-27-135 | Working Length,135,CM; | In distribution |
| PXB35-05-12-080 | Length 12 mm | In distribution |
| PXB35-09-27-135 | Outer Diameter 9 mm | In distribution |
| PXB35-08-27-080 | Outer Diameter 2.2 mm | In distribution |
| PXB35-06-27-080 | Outer Diameter 2.2 mm | In distribution |
| PXB35-07-17-080 | Working Length,80,Centimeter;Compatible Guidewire,.035,Inch;Rated Burst Pressure,12,AT;Nominal Pressure,10,AT; | In distribution |
| PXB35-06-17-080 | Catheter Gauge 6 Fr | In distribution |
| PXB35-09-57-135 | Length 57 mm | In distribution |
| PXB35-09-17-080 | Outer Diameter 9.0 mm | In distribution |
| PXB35-06-57-080 | Max. Guidewire.89 MM | In distribution |
| PXB35-10-17-135 | Length 17.0 mm | In distribution |
| PXB35-08-17-135 | Max. Guidewire.89 MM | In distribution |
| PXB35-08-17-135 | Catheter Gauge 6 Fr | In distribution |
| PXB35-10-57-080 | Length 57 mm | In distribution |
| PXB35-09-17-135 | Length 17.0 mm | In distribution |
| PXB35-05-37-135 | Catheter Gauge 6 Fr | In distribution |
| PXB35-09-57-135 | Max. Guidewire.89 MM | In distribution |
| PXB35-09-57-080 | Length 57 mm | In distribution |
| PXB35-10-27-080 | Outer Diameter 10 mm | In distribution |
| PXB35-07-37-080 | Catheter Gauge 6 Fr | In distribution |
| PXB35-06-27-135 | Outer Diameter 6 mm | In distribution |
| PXB35-07-57-080 | Max. Guidewire.89 MM | In distribution |
| PXB35-10-27-135 | Outer Diameter 10.0 mm | In distribution |
| PXB35-07-37-135 | Length 37.0 mm | In distribution |
| PXB35-07-17-080 | Catheter Gauge 6.0 Fr | In distribution |
| PXB35-05-57-135 | Length 57 mm | In distribution |
| PXB35-05-17-080 | Working Length,80,Centimeter;Compatible Guidewire,.035,Inch;Rated Burst Pressure,12,AT;Nominal Pressure,8,AT; | In distribution |
| PXB35-06-12-080 | Length 12.0 mm | In distribution |
| PXB35-07-12-080 | Outer Diameter 7.0 mm | In distribution |
| PXB35-10-27-135 | Length 27 mm | In distribution |
| PXB35-08-17-080 | Outer Diameter 2.2 mm | In distribution |
| PXB35-05-17-135 | Length 17 mm | In distribution |
| PXB35-07-17-135 | Outer Diameter 7 mm | In distribution |
| PXB35-05-37-135 | Outer Diameter 5.0 mm | In distribution |
| PXB35-09-27-080 | Length 27 mm | In distribution |
| PXB35-10-37-080 | Catheter Gauge 7.0 Fr | In distribution |
| PXB35-09-27-135 | Outer Diameter 9.0 mm | In distribution |
| PXB35-07-57-080 | Outer Diameter 2.2 mm | In distribution |
| PXB35-05-37-080 | Outer Diameter 2.2 mm | In distribution |
| PXB35-07-27-135 | Outer Diameter 7 mm | In distribution |
| PXB35-05-27-135 | Outer Diameter 5 mm | In distribution |
| PXB35-09-37-135 | Outer Diameter 9 mm | In distribution |
| PXB35-07-37-135 | Outer Diameter 7 mm | In distribution |
| PXB35-06-27-080 | Catheter Gauge 6.0 Fr | In distribution |
| PXB35-05-27-080 | Max. Guidewire.89 MM | In distribution |
| PXB35-10-37-080 | Outer Diameter 10 mm | In distribution |
| PXB35-10-37-135 | Outer Diameter 10 mm | In distribution |
| PXB35-09-27-080 | Max. Guidewire.89 MM | In distribution |
| PXB35-08-57-135 | Catheter Gauge 6 Fr | In distribution |
| PXB35-10-27-080 | Max. Guidewire.89 MM | In distribution |
| PXB35-09-17-135 | Catheter Gauge 7 Fr | In distribution |
| PXB35-09-17-080 | Outer Diameter 9 mm | In distribution |
| PXB35-08-37-135 | Outer Diameter 8 mm | In distribution |
| PXB35-06-57-080 | Length 57 mm | In distribution |
| PXB35-06-57-135 | Max. Guidewire.89 MM | In distribution |
| PXB35-07-12-080 | Working Length,80,Centimeter;Compatible Guidewire,.035,Inch;Rated Burst Pressure,12,AT;Nominal Pressure,10,AT; | In distribution |
| PXB35-06-17-135 | Length 17.0 mm | In distribution |
| PXB35-06-37-080 | Length 37.0 mm | In distribution |
| PXB35-05-57-080 | Outer Diameter 2.2 mm | In distribution |
| PXB35-10-17-080 | Outer Diameter 10 mm | In distribution |
| PXB35-09-37-080 | Length 37 mm | In distribution |
| PXB35-07-57-135 | Catheter Gauge 6 Fr | 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
Recalls Naming This Product
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| ev3, Inc. | 510(k) number | 2008-07-01 | Not classified | Employee error | ev3, Inc. has determined that specific lots of the Visi-Pro” BE Stent system may not have adequate securement of the stent to the delivery system and may have a larger diameter/profile than intended. | 66 | 2011-12-10 |
| ev3, Inc. | 510(k) number | 2008-07-01 | Not classified | Employee error | ev3, Inc. has determined that specific lots of the Visi-Pro” BE Stent system may not have adequate securement of the stent to the delivery system and may have a larger diameter/profile than intended. | 212 | 2011-12-10 |
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.