Aero®
37 catalogue numbers from 00884450691021, listed by Merit Medical Systems, Inc., United States, under Prosthesis, Tracheal, Expandable. 1 manufacturer in China is registered for this product code.
1manufacturer
37catalogue numbers in this listing
2510(k) clearances naming this product 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 | Merit Medical Systems, Inc., United States |
|---|---|
| FDA product code | JCT |
| Device type | Prosthesis, Tracheal, Expandable |
| Device class | Class 2 |
| Regulation | 21 CFR 878.3720 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2023-09-16 |
| Record revised | 2021-11-08 (version 5) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 00884450691021 | Expanded Stent Length (mm)-60 mm | In distribution |
| 00884450030769 | Expanded Stent Length (mm)-30 mm | In distribution |
| 00884450030806 | Expanded Stent Length (mm)-80 mm | In distribution |
| 00884450030820 | Expanded Stent Length (mm)-60 mm | In distribution |
| 00884450690970 | Nominal Stent Diameter (mm)-18 mm | In distribution |
| 00884450030783 | Nominal Stent Diameter (mm)-16 mm | In distribution |
| 00884450624944 | Nominal Stent Diameter (mm)-10 mm | In distribution |
| 00884450030844 | Expanded Stent Length (mm)-40 mm | In distribution |
| 00884450691113 | Expanded Stent Length (mm)-80 mm | In distribution |
| 00884450691083 | Nominal Stent Diameter (mm)-20 mm | In distribution |
| 00884450030691 | Expanded Stent Length (mm)-20 mm | In distribution |
| 00884450030714 | Expanded Stent Length (mm)-40 mm | In distribution |
| 00884450625309 | Expanded Stent Length (mm)-30 mm | In distribution |
| 00884450030851 | Nominal Stent Diameter (mm)-20 mm | In distribution |
| 00884450030868 | Expanded Stent Length (mm)-80 mm | In distribution |
| G | Expanded Stent Length (mm)-40 mm | In distribution |
| G | Expanded Stent Length (mm)-30 mm | In distribution |
| 00884450030813 | Nominal Stent Diameter (mm)-18 mm | In distribution |
| 00884450691007 | Nominal Stent Diameter (mm)-18 mm | In distribution |
| 00884450030721 | Expanded Stent Length (mm)-20 mm | In distribution |
| 00884450691069 | Nominal Stent Diameter (mm)-20 mm | In distribution |
| G | Expanded Stent Length (mm)-20 mm | In distribution |
| 00884450030776 | Expanded Stent Length (mm)-40 mm | In distribution |
| 00884450691014 | Nominal Stent Diameter (mm)-16 mm | In distribution |
| G | Expanded Stent Length (mm)-20 mm | In distribution |
| G | Nominal Stent Diameter (mm)-14 mm | In distribution |
| 00884450691038 | Expanded Stent Length (mm)-80 mm | In distribution |
| 00884450030752 | Nominal Stent Diameter (mm)-14 mm | In distribution |
| 00884450030837 | Nominal Stent Diameter (mm)-18 mm | In distribution |
| G | Nominal Stent Diameter (mm)-10 mm | In distribution |
| 00884450030745 | Nominal Stent Diameter (mm)-12 mm | In distribution |
| 00884450030738 | Expanded Stent Length (mm)-30 mm | In distribution |
| G | Expanded Stent Length (mm)-40 mm | In distribution |
| G | Expanded Stent Length (mm)-30 mm | In distribution |
| 00884450030707 | Expanded Stent Length (mm)-30 mm | In distribution |
| 00884450030790 | Nominal Stent Diameter (mm)-16 mm | In distribution |
| G | Nominal Stent Diameter (mm)-10 mm | 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 |
| 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K181200 | 2018-09-21 |
| K140382 | 2014-11-25 |
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.