Wallstent™ RP Endoprosthesis
32 catalogue numbers from M001711010, listed by Boston Scientific Corporation, United States, under Prosthesis, Tracheal, Expandable. 1 manufacturer in China is registered for this product code.
1manufacturer
32catalogue numbers in this listing
7510(k) clearances naming this product code
40recalls on this code
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 | Boston Scientific Corporation, United States |
|---|---|
| FDA product code | JCT |
| Device type | Prosthesis, Tracheal, Expandable |
| Device class | Class 2 |
| Regulation | 21 CFR 878.3720 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2015-09-24 |
| Record revised | 2022-12-20 (version 3) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| M001711010 | 20 mm Length | In distribution |
| M001711040 | 5 mm Stent Diameter | In distribution |
| M001711130 | 60 mm Length | In distribution |
| M001711220 | 7 mm Stent Diameter | In distribution |
| M001711170 | 20 mm Length | In distribution |
| M001711070 | 135 cm Effective Length | In distribution |
| M001711030 | 5 mm Diameter | In distribution |
| M001711230 | 135 cm Effective Length | In distribution |
| M001711140 | 6 mm Stent Diameter | In distribution |
| M001711100 | 75 cm Effective Length | In distribution |
| M001711390 | 135 cm Effective Length | In distribution |
| M001711180 | 7 mm Stent Diameter | In distribution |
| M001711080 | 6 mm Stent Diameter | In distribution |
| M001711000 | 20 mm Stent Length | In distribution |
| M001711020 | 5 mm Stent Diameter | In distribution |
| M001711290 | 135 cm Effective Length | In distribution |
| M001711150 | 135 cm Effective Length | In distribution |
| M001711250 | 135 cm Effective Length | In distribution |
| M001711330 | 135 cm Effective Length | In distribution |
| M001711200 | 60 mm Stent Length | In distribution |
| M001711110 | 45 mm Length | In distribution |
| M001711120 | 75 cm Effective Length | In distribution |
| M001711350 | 10 mm Diameter | In distribution |
| M001711050 | 5 mm Diameter | In distribution |
| M001711060 | 5 mm Stent Diameter | In distribution |
| M001711160 | 75 cm Effective Length | In distribution |
| M001711210 | 135 cm Effective Length | In distribution |
| M001711190 | 135 cm Effective Length | In distribution |
| M001711090 | 135 cm Effective Length | In distribution |
| M001711370 | 135 cm Effective Length | In distribution |
| M001711270 | 8 mm Diameter | In distribution |
| M001711310 | 135 cm Effective Length | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Hanarostent® Trachea/Bronchium(CCC) | M.I.Tech Co Ltd | 84 |
| Bonastent® Tracheal/Bronchial | Sewoon Medical Co., Ltd. | 83 |
| Aero® | Merit Medical Systems, Inc. | 37 |
| Ultraflex™ Tracheobronchial | Boston Scientific Corporation | 36 |
| iCAST | Atrium Medical Corporation | 34 |
| 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K230269 | 2023-07-14 |
| K152842 | 2016-05-19 |
| K141584 | 2014-10-16 |
| K121048 | 2012-08-03 |
| K003100 | 2000-12-20 |
| K992510 | 1999-11-18 |
| K963241 | 1996-11-14 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2016-03-18 | Class II | Process control | Mislabeled: 10mm diameter x 30mm length Ultraflex Tracheobronchial stents were labeled as 12mm diameter x 30mm | 4 units | 2016-08-26 |
| 2011-05-25 | Not classified | Labeling False and Misleading | Boston Scientific is initiating an important field correction related to WALLSTENT”, WALLSTENT” RP, and WALLGRAFT Tracheobronchial Endoprosthesis products. This letter is intended to clarify and re-emphasize that U.S. WALLSTENT”, WALLSTENT” | 23,218 TOTAL FOR ALL PRODUCTS | 2012-08-10 |
| 2011-05-25 | Not classified | Labeling False and Misleading | Boston Scientific is initiating an important field correction related to WALLSTENT”, WALLSTENT” RP, and WALLGRAFT Tracheobronchial Endoprosthesis products. This letter is intended to clarify and re-emphasize that U.S. WALLSTENT”, WALLSTENT” | 23,218 FOR ALL PRODUCTS | 2012-08-10 |
| 2010-07-15 | Not classified | Process control | Units have excessive fraying of the deployment suture thread, as a result, these devices may experience a suture break during deployment. | 10 units | 2011-10-14 |
| 2010-07-15 | Not classified | Process control | Units have excessive fraying of the deployment suture thread, as a result, these devices may experience a suture break during deployment. | 5 units | 2011-10-14 |
| 2010-07-15 | Not classified | Process control | Units have excessive fraying of the deployment suture thread, as a result, these devices may experience a suture break during deployment. | 1 unit | 2011-10-14 |
| 2010-07-15 | Not classified | Process control | Units have excessive fraying of the deployment suture thread, as a result, these devices may experience a suture break during deployment. | 11 units | 2011-10-14 |
| 2010-07-15 | Not classified | Process control | Units have excessive fraying of the deployment suture thread, as a result, these devices may experience a suture break during deployment. | 15 units | 2011-10-14 |
| 2010-07-15 | Not classified | Process control | Units have excessive fraying of the deployment suture thread, as a result, these devices may experience a suture break during deployment. | 9 units | 2011-10-14 |
| 2010-05-17 | Not classified | Device Design | Suture related device failures during deployment and repositioning of the stent | 2011-10-20 | |
| 2010-05-17 | Not classified | Device Design | Suture related device failures during deployment and repositioning of the stent | 2011-10-20 | |
| 2010-05-17 | Not classified | Device Design | Suture related device failures during deployment and repositioning of the stent | 2011-10-20 | |
| 2010-05-17 | Not classified | Device Design | Suture related device failures during deployment and repositioning of the stent | 2011-10-20 | |
| 2010-05-17 | Not classified | Device Design | Suture related device failures during deployment and repositioning of the stent | 2011-10-20 | |
| 2010-05-17 | Not classified | Device Design | Suture related device failures during deployment and repositioning of the stent | 2011-10-20 | |
| 2010-05-17 | Not classified | Device Design | Suture related device failures during deployment and repositioning of the stent | 2011-10-20 | |
| 2010-05-17 | Not classified | Device Design | Suture related device failures during deployment and repositioning of the stent | 2011-10-20 | |
| 2010-05-17 | Not classified | Device Design | Suture related device failures during deployment and repositioning of the stent | 2011-10-20 | |
| 2010-05-17 | Not classified | Device Design | Suture related device failures during deployment and repositioning of the stent | 2011-10-20 | |
| 2010-05-17 | Not classified | Device Design | Suture related device failures during deployment and repositioning of the stent | 2011-10-20 | |
| 2010-05-17 | Not classified | Device Design | Suture related device failures during deployment and repositioning of the stent | 2011-10-20 | |
| 2010-05-17 | Not classified | Device Design | Suture related device failures during deployment and repositioning of the stent | Prosthesis, tracheal, expandable | 2011-10-20 |
| 2010-05-17 | Not classified | Device Design | Suture related device failures during deployment and repositioning of the stent | 2011-10-20 | |
| 2010-05-17 | Not classified | Device Design | Suture related device failures during deployment and repositioning of the stent | 2011-10-20 | |
| 2010-05-17 | Not classified | Device Design | Suture related device failures during deployment and repositioning of the stent | 2011-10-20 | |
| 2010-05-17 | Not classified | Device Design | Suture related device failures during deployment and repositioning of the stent | 2011-10-20 | |
| 2010-05-17 | Not classified | Device Design | Suture related device failures during deployment and repositioning of the stent | 2011-10-20 | |
| 2010-05-17 | Not classified | Device Design | Suture related device failures during deployment and repositioning of the stent | 2011-10-20 | |
| 2010-05-17 | Not classified | Device Design | Suture related device failures during deployment and repositioning of the stent | 2011-10-20 | |
| 2010-05-17 | Not classified | Device Design | Suture related device failures during deployment and repositioning of the stent | 2011-10-20 | |
| 2010-05-17 | Not classified | Device Design | Suture related device failures during deployment and repositioning of the stent | 2011-10-20 | |
| 2010-05-17 | Not classified | Device Design | Suture related device failures during deployment and repositioning of the stent | 2011-10-20 | |
| 2010-05-17 | Not classified | Device Design | Suture related device failures during deployment and repositioning of the stent | 2011-10-20 | |
| 2010-05-17 | Not classified | Device Design | Suture related device failures during deployment and repositioning of the stent | 2011-10-20 | |
| 2010-05-17 | Not classified | Device Design | Suture related device failures during deployment and repositioning of the stent | 2011-10-20 | |
| 2010-05-17 | Not classified | Device Design | Suture related device failures during deployment and repositioning of the stent | 2011-10-20 | |
| 2010-05-17 | Not classified | Device Design | Suture related device failures during deployment and repositioning of the stent | 2011-10-20 | |
| 2010-05-17 | Not classified | Device Design | Suture related device failures during deployment and repositioning of the stent | 2011-10-20 | |
| 2010-05-17 | Not classified | Device Design | Suture related device failures during deployment and repositioning of the stent | 2011-10-20 | |
| 2010-05-17 | Not classified | Device Design | Suture related device failures during deployment and repositioning of the stent | 2011-10-20 |
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.