SpyGlass™ Discover
Balloon Dilation Catheter
4manufacturers in China registered for this device type
3catalogue numbers in this listing
2510(k) clearances naming this product code
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 | Boston Scientific Corporation, 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 | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2022-06-03 |
| Record revised | 2024-12-23 (version 2) |
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 |
| Sizes | Length 40 cm; balloon diameter 6 to 8 mm; balloon length 40 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| M00543000 | Length 40 cm | In distribution |
| M00543040 | Balloon Length 40 mm | In distribution |
| M00543010 | Balloon Length 40 mm | 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 |
| Fogarty | Edwards Lifesciences Technology Sarl | 6 |
| Silicone Y Drainage Tube | Fortune Medical Instrument Corp. | 6 |
| Duraglide | ConMed Corporation | 5 |
Showing 12 of 28. All products under Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K212582 | 2022-05-06 |
| K931619 | 1993-08-20 |
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.