Contour™ Injection Stent Set
Injection Stent Set
4manufacturers in China registered for this device type
14catalogue numbers in this listing
12510(k) clearances naming this product code
5recalls on this code
Who Else Makes It
Concentrated in Shanghai (2), Zhejiang (1), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Chuangxiang Medical Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 27 |
| Alton Shanghai Medical Instruments Co Ltd | Shanghai | Shanghai | Complaint-file establishment | 20 |
| BQ Plus Medical Co., Ltd. | Songjiang | Shanghai | Contract manufacturer | 13 |
| Shenzhen Trious Medical Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 6 |
Record
| Listed by | Boston Scientific Corporation, United States |
|---|---|
| FDA product code | FAD |
| Device type | Stent, Ureteral |
| Device class | Class 2 |
| Regulation | 21 CFR 876.4620 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2015-09-24 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| M0061856220 | 7 F Stent Diameter | In distribution |
| M0061856070 | 24 cm Effective Length | In distribution |
| M0061856190 | 2.3 mm Stent Diameter | In distribution |
| M0061856210 | 2.3 mm Stent Diameter | In distribution |
| M0061856130 | 2.0 mm Stent Diameter | In distribution |
| M0061856080 | 1.6 mm Stent Diameter | In distribution |
| M0061856160 | 2.0 mm Stent Diameter | In distribution |
| M0061856170 | 7 F Stent Diameter | In distribution |
| M0061856090 | 1.6 mm Stent Diameter | In distribution |
| M0061856120 | 6 F Stent Diameter | In distribution |
| M0061856180 | 22 cm Effective Length | In distribution |
| M0061856200 | 7 F Stent Diameter | In distribution |
| M0061856150 | 6 F Stent Diameter | In distribution |
| M0061856140 | 26 cm Effective Length | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Porges Coloplast | Coloplast A/S | 509 |
| Polaris™ Ultra | Boston Scientific Corporation | 406 |
| Universa | Cook Incorporated | 384 |
| Percuflex™ Plus | Boston Scientific Corporation | 300 |
| Polaris™ Loop | Boston Scientific Corporation | 232 |
| ImaJin | Coloplast A/S | 219 |
| Contour™ | Boston Scientific Corporation | 205 |
| Percuflex™ | Boston Scientific Corporation | 152 |
| Tecoflex | Gyrus Acmi, Inc. | 92 |
| Vortek | Coloplast A/S | 92 |
| Sof-Flex | Cook Incorporated | 60 |
| Tria™ Firm | Boston Scientific Corporation | 58 |
Showing 12 of 131. All products under Stent, Ureteral
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K250824 | 2025-04-15 |
| K211934 | 2022-11-10 |
| K200260 | 2021-04-26 |
| K191446 | 2020-01-02 |
| K191609 | 2019-08-16 |
| K190603 | 2019-05-24 |
| K163399 | 2017-06-22 |
| K141344 | 2014-10-17 |
| K030503 | 2003-03-17 |
| K013784 | 2002-08-08 |
| K010002 | 2001-01-22 |
| K974541 | 1998-02-09 |
Recalls
2 of these are 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 |
|---|---|---|---|---|---|
| 2020-11-16 | Class II | Process design | Trace amounts of metallic debris were found on the stent related to the manufacturing process. The debris was confirmed to be particles of nickel. | 458 units | |
| 2020-11-16 | Class II | Process design | Trace amounts of metallic debris were found on the stent related to the manufacturing process. The debris was confirmed to be particles of nickel. | 458 units | |
| 2009-03-18 | Not classified | Labeling False and Misleading | Boston Scientific Corporation is initiating an urgent Field Correction related to its Flexima and Percuflex Drainage Catheter Family (Pigtail Style). During the attempted removal of the device, sutures were separated from the catheter and | 586,276 US; 276,013 OUS total for all products | 2012-02-23 |
| 2009-03-18 | Not classified | Labeling False and Misleading | Boston Scientific Corporation is initiating an urgent Field Correction related to its Flexima and Percuflex Drainage Catheter Family (Pigtail Style). During the attempted removal of the device, sutures were separated from the catheter and | 586,276 US; 276,013 OUS total for all products | 2012-02-23 |
| 2006-05-10 | Not classified | Other | Instructions on how to inject are not included in the package. | 29 | 2006-11-01 |
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.