Aero DV®
27 catalogue numbers from 00884450031018, listed by Merit Medical Systems, Inc., United States, under Prosthesis, Tracheal, Expandable. 1 manufacturer in China is registered for this product code.
1manufacturer
27catalogue 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 | 2016-09-20 |
| Record revised | 2021-11-08 (version 5) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Sizes | Stent length 60 mm; stent diameter 18 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 00884450031018 | Expanded Stent Length (mm)-80 mm | In distribution |
| 00884450031001 | Nominal Stent Diameter (mm)-20 mm | In distribution |
| 00884450030981 | Nominal Stent Diameter (mm)-18 mm | In distribution |
| 00884450030905 | Expanded Stent Length (mm)-20 mm | In distribution |
| 00884450690734 | Expanded Stent Length (mm)-20 mm | In distribution |
| 00884450030899 | Expanded Stent Length (mm)-40 mm | In distribution |
| 00884450690741 | Expanded Stent Length (mm)-30 mm | In distribution |
| 00884450030950 | Nominal Stent Diameter (mm)-16 mm | In distribution |
| 00884450030967 | Nominal Stent Diameter (mm)-18 mm | In distribution |
| D | Expanded Stent Length (mm)-40 mm | In distribution |
| D | Stent Length 60 mm | In distribution |
| 00884450030998 | Expanded Stent Length (mm)-40 mm | In distribution |
| 00884450030974 | Expanded Stent Length (mm)-60 mm | In distribution |
| 00884450691403 | Nominal Stent Diameter (mm)-18 mm | In distribution |
| 00884450690789 | Nominal Stent Diameter (mm)-16 mm | In distribution |
| 00884450030943 | Nominal Stent Diameter (mm)-16 mm | In distribution |
| 00884450030929 | Expanded Stent Length (mm)-40 mm | In distribution |
| 00884450690857 | Expanded Stent Length (mm)-40 mm | In distribution |
| D | Expanded Stent Length (mm)-60 mm | In distribution |
| 00884450030882 | Nominal Stent Diameter (mm)-12 mm | In distribution |
| 00884450690819 | Nominal Stent Diameter (mm)-14 mm | In distribution |
| 00884450690840 | Expanded Stent Length (mm)-60 mm | In distribution |
| 00884450690864 | Nominal Stent Diameter (mm)-20 mm | In distribution |
| 00884450030875 | Expanded Stent Length (mm)-20 mm | In distribution |
| 00884450030936 | Nominal Stent Diameter (mm)-16 mm | In distribution |
| D | Nominal Stent Diameter (mm)-12 mm | In distribution |
| 00884450030912 | Nominal Stent Diameter (mm)-14 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 |
| 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 |
| 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.