Bonastent® Tracheal/Bronchial
83 catalogue numbers from BTB-120509, listed by Sewoon Medical Co., Ltd., South Korea, under Prosthesis, Tracheal, Expandable. 1 manufacturer in China is registered for this product code.
1manufacturer
83catalogue numbers in this listing
Who Else Makes It
Registered in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Micro-Tech (Nanjing) Co., Ltd. | Nan Jing | Jiangsu | Contract manufacturer | 49 |
Record
| Listed by | Sewoon Medical Co., Ltd., South Korea |
|---|---|
| FDA product code | JCT |
| Device type | Prosthesis, Tracheal, Expandable |
| Device class | Class 2 |
| Regulation | 21 CFR 878.3720 |
| Establishment | Contract manufacturer, Contract steriliser, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K140472 |
| Record published | 2017-03-03 |
| Record revised | 2021-10-25 (version 5) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| BTB-120509 | 50mm Stent Length | In distribution |
| BTB-200409 | 40mm Stent Length | In distribution |
| BTB-072012 | 20mm Stent Length | In distribution |
| BTB-100505 | 50mm Stent Length | In distribution |
| BTB-100709 | 70mm Stent Length | In distribution |
| BTB-140705 | 70mm Stent Length | In distribution |
| BTB-140309 | 30mm Stent Diameter mm Stent Length | In distribution |
| BTB-160709 | 70mm Stent Length | In distribution |
| BTB-120405 | 40mm Stent Length | In distribution |
| BTB-160409 | 40mm Stent Length | In distribution |
| BTB-180509 | 50mm Stent Length | In distribution |
| BTB-071512 | 15mm Stent Length | In distribution |
| BTB-160305 | 30mm Stent Diameter mm Stent Length | In distribution |
| BTB-180305 | 30mm Stent Length | In distribution |
| BTB-200509 | 50mm Stent Length | In distribution |
| BTB-180405 | 40mm Stent Length | In distribution |
| BTB-120409 | 40mm Stent Length | In distribution |
| BTB-140709 | 70mm Stent Length | In distribution |
| BTB-160605 | 60mm Stent Length | In distribution |
| BTB-180409 | 40mm Stent Length | In distribution |
| BTB-200605 | 60mm Stent Length | In distribution |
| BTB-100605 | 60mm Stent Length | In distribution |
| BTB-120705 | 70mm Stent Length | In distribution |
| BTB-180609 | 60mm Stent Length | In distribution |
| BTB-140305 | 30mm Stent Length | In distribution |
| BTB-200709 | 70mm Stent Length | In distribution |
| BTB-200305 | 30mm Stent Length | In distribution |
| BTB-120605 | 60mm Stent Length | In distribution |
| BTB-120809 | 80mm Stent Length | In distribution |
| BTB-200505 | 50mm Stent Length | In distribution |
| BTB-160405 | 40mm Stent Length | In distribution |
| BTB-140405 | 40mm Stent Length | In distribution |
| BTB-100409 | 40mm Stent Length | In distribution |
| BTB-160509 | 50mm Stent Length | In distribution |
| BTB-100609 | 60mm Stent Length | In distribution |
| BTB-160805 | 80mm Stent Length | In distribution |
| BTB-140609 | 60mm Stent Diameter mm Stent Length | In distribution |
| BTB-120805 | 80mm Stent Length | In distribution |
| BTB-120709 | 70mm Stent Length | In distribution |
| BTB-120609 | 60mm Stent Length | In distribution |
| BTB-120305 | 30mm Stent Length | In distribution |
| BTB-160809 | 80mm Stent Length | In distribution |
| BTB-100405 | 40mm Stent Length | In distribution |
| BTB-160705 | 70mm Stent Length | In distribution |
| BTB-081512 | 15mm Stent Length | In distribution |
| BTB-140805 | 80mm Stent Length | In distribution |
| BTB-120505 | 50mm Stent Length | In distribution |
| BTB-200805 | 80mm Stent Length | In distribution |
| BTB-200309 | 30mm Stent Length | In distribution |
| BTB-180709 | 70mm Stent Length | In distribution |
| BTB-062012 | 20mm Stent Length | In distribution |
| BTB-100305 | 30mmStent Length | In distribution |
| BTB-140809 | 80mm Stent Length | In distribution |
| BTB-180809 | 80mm Stent Length | In distribution |
| BTB-100309 | 30mm Stent Length | In distribution |
| BTB-081012 | 10mm Stent Length | In distribution |
| BTB-140505 | 50mm Stent Diameter mm Stent Length | In distribution |
| BTB-082012 | 20mm Stent Length | In distribution |
| BTB-160609 | 60mm Stent Length | In distribution |
| BTB-140605 | 60mm Stent Length | In distribution |
| BTB-100809 | 80mm Stent Length | In distribution |
| BTB-180605 | 60mm Stent Length | In distribution |
| BTB-180309 | 30mm Stent Length | In distribution |
| BTB-100509 | 50mm Stent Length | In distribution |
| BTB-200609 | 60mm Stent Length | In distribution |
| BTB-061012 | 10mm Stent Length | In distribution |
| BTB-140409 | 40mm Stent Diameter mm Stent Length | In distribution |
| BTB-160505 | 50mm Stent Diameter mm Stent Length | In distribution |
| BTB-140509 | 50mm Stent Length | In distribution |
| BTB-140209 | 20mm Stent Length | In distribution |
| BTB-200809 | 80mm Stent Length | In distribution |
| BTB-180705 | 70mm Stent Length | In distribution |
| BTB-120309 | 30mm Stent Length | In distribution |
| BTB-101512 | 15mm Stent Length | In distribution |
| BTB-061512 | 15mm Stent Length | In distribution |
| BTB-200705 | 70mm Stent Length | In distribution |
| BTB-200405 | 40mm Stent Length | In distribution |
| BTB-071012 | 10mm Stent Length | In distribution |
| BTB-100705 | 70mm Stent Length | In distribution |
| BTB-180505 | 50mm Stent Length | In distribution |
| BTB-160309 | 30mm Stent Length | In distribution |
| BTB-100209 | 20mm Stent Length | In distribution |
| BTB-180805 | 80mm Stent Length | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Hanarostent® Trachea/Bronchium(CCC) | M.I.Tech Co Ltd | 84 |
| Aero® | Merit Medical Systems, Inc. | 37 |
| Ultraflex™ Tracheobronchial | Boston Scientific Corporation | 36 |
| iCAST | Atrium Medical Corporation | 34 |
| Wallstent™ RP Endoprosthesis | Boston Scientific Corporation | 32 |
| Tracheal Stent system (Y-shaped) | Micro-Tech (Nanjing) Co., Ltd. | 27 |
| Aero DV® | Merit Medical Systems, Inc. | 27 |
| Wallgraft® | Boston Scientific Corporation | 25 |
| AEROmini® | Merit Medical Systems, Inc. | 25 |
| Through the Scope Tracheal Stent System | Micro-Tech (Nanjing) Co., Ltd. | 17 |
| Wallstent® Endoprosthesis | Boston Scientific Corporation | 16 |
| Gianturco-Rosch Cook-Z | Cook Incorporated | 5 |
Showing 12 of 14. All products under Prosthesis, Tracheal, Expandable
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.