Fogarty
Fogarty Biliary Balloon Probe 5F 40CM
4manufacturers in China registered for this device type
6catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (3), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jiangsu Vedkang Medical Science and Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 20 |
| Hangzhou AGS MedTech Co., Ltd. | Hangzhou | Zhejiang | Repacker / relabeller | 19 |
| Anrei Medical (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 12 |
| Zhejiang Soudon Medical Technology Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 9 |
Record
| Listed by | Edwards Lifesciences Technology Sarl, United States |
|---|---|
| FDA product code | GCA |
| Device type | Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5010 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| 510(k) | K193379 |
| Record published | 2020-08-31 |
| Record revised | 2020-11-19 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Store in a cool, dry place. |
| Packaging | Shipper of 5 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 410405FP | CATHETER FRENCH SIZE: 5F (1.67MM), USABLE LENGTH: 40CM | In distribution |
| 410235F | FRENCH SIZE: 5F (1.67MM), MAXIMUM LIQUID CAPACITY: 0.4ML, MAXIMUM AIR CAPACITY: 0.8ML, MAXIMUM INFLATED BALLOON DIAMETER: 8MM | In distribution |
| 410236FP | CATHETER FRENCH SIZE: 6F (2.00MM), USABLE LENGTH: 23CM | In distribution |
| 410236F | FRENCH SIZE: 6F (2.0MM), MAXIMUM LIQUID CAPACITY: 1.25ML, MAXIMUM AIR CAPACITY: 2.5ML, MAXIMUM INFLATED BALLOON DIAMETER: 13MM | In distribution |
| 410235FP | CATHETER FRENCH SIZE: 5F (1.67MM), USABLE LENGTH: 23CM | In distribution |
| 410405F | FRENCH SIZE: 5F (1.67MM), MAXIMUM LIQUID CAPACITY: 0.4ML, MAXIMUM AIR CAPACITY: 0.8ML, MAXIMUM INFLATED BALLOON DIAMETER: 8MM | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection | Hangzhou AGS MedTech Co., Ltd. | 24 |
| Cook | Cook Incorporated | 19 |
| Tri-Ex | Cook Incorporated | 15 |
| Silicone T Drainage Tube | Fortune Medical Instrument Corp. | 10 |
| Silicone T Drainage Set With Eyes | Fortune Medical Instrument Corp. | 9 |
| Silicone T Drainage Tube With Eyes | Fortune Medical Instrument Corp. | 8 |
| Ring | Cook Incorporated | 8 |
| Silicone T Drainage Set | Fortune Medical Instrument Corp. | 7 |
| Taxi | Lake Region Medical Limited | 7 |
| Silicone Y Drainage Tube | Fortune Medical Instrument Corp. | 6 |
| Duraglide | ConMed Corporation | 5 |
| Fusion Quattro | Cook Incorporated | 4 |
Showing 12 of 28. All products under Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection
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.