Ultraflex™ Tracheobronchial
Proximal Release Stent System
1manufacturer
36catalogue 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 | 2021-02-19 (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 |
|---|---|---|
| M00576670 | 40 mm Stent Length | In distribution |
| M00576610 | 40 mm Stent Length | In distribution |
| M00576460 | 12 mm Stent Diameter | In distribution |
| M00576440 | 40 mm Effective Length | In distribution |
| M00576570 | 14 mm Stent Diameter | In distribution |
| M00576560 | 40 mm Stent Length | In distribution |
| M00576370 | 40 mm Effective Length | In distribution |
| M00576580 | 40 mm Stent Length | In distribution |
| M00576660 | 80 mm Stent Length | In distribution |
| M00576470 | 20 mm Effective Length | In distribution |
| M00576530 | 10 mm Stent Diameter | In distribution |
| M00576620 | 60 mm Stent Length | In distribution |
| M00576340 | 60 mm Effective Length | In distribution |
| M00576360 | 60 mm Effective Length | In distribution |
| M00576490 | 60 mm Effective Length | In distribution |
| M00576300 | 30 mm Effective Length | In distribution |
| M00576450 | 12 mm Stent Diameter | In distribution |
| M00576600 | 14 mm Stent Diameter | In distribution |
| M00576320 | 14 mm Stent Diameter | In distribution |
| M00576520 | 8 mm Stent Diameter | In distribution |
| M00576410 | 8 mm Stent Diameter | In distribution |
| M00576540 | 40 mm Stent Length | In distribution |
| M00576350 | 40 mm Effective Length | In distribution |
| M00576480 | 40 mm Effective Length | In distribution |
| M00576680 | 60 mm Stent Length | In distribution |
| M00576650 | 18 mm Stent Diameter | In distribution |
| M00576640 | 40 mm Stent Length | In distribution |
| M00576420 | 40 mm Effective Length | In distribution |
| M00576310 | 12 mm Stent Diameter | In distribution |
| M00576630 | 80 mm Stent Length | In distribution |
| M00576430 | 20 mm Effective Length | In distribution |
| M00576690 | 80 mm Stent Length | In distribution |
| M00576380 | 60 mm Effective Length | In distribution |
| M00576590 | 14 mm Stent Diameter | In distribution |
| M00576330 | 40 mm Effective Length | In distribution |
| M00576550 | 12 mm Stent Diameter | 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 |
| 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
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.