Trachealator Non-Occlusive Airway Dilation Balloon
The FDA filing identifies Trachealator as the marketing name for the D35 Airway Dilation Catheter. Its parallel balloons apply outward radial force while creating an inter-balloon space for…
The FDA filing identifies Trachealator as the marketing name for the D35 Airway Dilation Catheter.
Its parallel balloons apply outward radial force while creating an inter-balloon space for airflow, so the airway is not occluded during dilation.
Use and Configuration
The catheter is indicated for dilation techniques to open or expand airway stenosis and is supplied with a double-ended, PTFE-coated stainless-steel guidewire. The package includes a 1,500 mm double-ended PTFE-coated stainless-steel guidewire.
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 | 2026-05-20 |
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 |
| Storage | Storage environment temperature 5 to 25 °C |
| Sizes | Balloon diameter 6 to 18 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TRD1-12040 | Balloon Diameter 12 mm | In distribution |
| TRD1-07030 | Balloon Diameter 7 mm | In distribution |
| TRD1-10030 | Balloon Diameter 10 mm | In distribution |
| TRD1-14540 | Balloon Diameter 14.5 mm | In distribution |
| TRD1-06030 | Balloon Diameter 6 mm | In distribution |
| TRD1-16040 | Balloon Diameter 16 mm | In distribution |
| TRD1-18040 | Balloon Diameter 18 mm | In distribution |
| TRD1-08030 | Balloon Diameter 8 mm | In distribution |
| TRD1-09030 | Balloon Diameter 9 mm | 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 |
| 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 |
| Compass Steerable Needle | Serpex Medical, Inc. | 2 |
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.