Trachealator
The FDA filing identifies Trachealator as a D35 Airway Dilation Catheter. The summary compares its balloon-cluster configuration and dimensions with predicate and reference catheters. The…
The FDA filing identifies Trachealator as a D35 Airway Dilation Catheter. The summary compares its balloon-cluster configuration and dimensions with predicate and reference catheters.
The indication is dilation to open or expand airway stenosis. The device description says deployed balloons provide outward radial force while maintaining an inter-balloon passage for airflow.
Listed Item
The Trachealator Non-occlusive Airway Dilation Balloon is comprised of a single lumen, over-the wire, catheter with a clustered balloon system near the distal tip. The balloon cluster, when inflated, features a inter balloon space to avoid airway occlusion during deployment. The inflated balloon cluster generates a strong outward force for dilation of airway strictures. A guidewire is provided to facilitate the advancement of the Trachealator Non-occlusive Airway Dilation Balloon to the desired location.
Catheter Design
The filing describes six- or eight-balloon clusters arranged in parallel in a circular configuration.
Who Else Makes It
Concentrated in Jiangsu (2), Shanghai (2), Guangdong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Smartdata Suzhou Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 11 |
| Micro-Tech (Nanjing) Co., Ltd. | Nan Jing | Jiangsu | Contract manufacturer | 49 |
| Alton Shanghai Medical Instruments Co Ltd | Shanghai | Shanghai | Complaint-file establishment | 20 |
| BQ Plus Medical Co., Ltd. | Songjiang | Shanghai | Contract manufacturer | 13 |
| Dongguan TT Medical, Inc. | Dongguan | Guangdong | Manufacturer | 4 |
Record
| Listed by | Disa Medinotec (PTY) Ltd, South Africa |
|---|---|
| FDA product code | KTI |
| Device type | Bronchoscope Accessory |
| Device class | Class 2 |
| Regulation | 21 CFR 874.4680 |
| Establishment | Manufacturer |
| 510(k) | K211894 |
| Record published | 2023-08-02 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TRD1 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Bronchoscope Accessory | Richard Wolf Gmbh | 42 |
| MultiStage® | Dongguan TT Medical, Inc. | 24 |
| Elation™ | Merit Medical Systems, Inc. | 23 |
| Inspira AIR | Acclarent, Inc. | 14 |
| Texas | Richard Wolf Gmbh | 10 |
| Trachealator Non-occlusive Airway Dilation Balloon | Disa Medinotec (PTY) Ltd | 9 |
| Pilling | Teleflex Medical LLC | 8 |
| CRE Pulmonary | Boston Scientific Corporation | 6 |
| Single Use Aspiration Needle | Olympus Medical Systems Corp. | 5 |
| Cook | Cook Incorporated | 3 |
| Areus(TM) Endobronchial Ultrasound Aspiration Needle | Micro-Tech (Nanjing) Co., Ltd. | 3 |
| Trident(TM) Endobronchial Ultrasound Biopsy Needle | Micro-Tech (Nanjing) Co., Ltd. | 3 |
Showing 12 of 37. All products under Bronchoscope Accessory
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K211894 | 2021-11-24 |
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.