MultiStage®
The FDA filing identifies the MultiStage Balloon Dilatation Catheter for dilation of strictures in the airway tree. The catheter is designed to pass over a 0.035-inch guidewire or through a…
The FDA filing identifies the MultiStage Balloon Dilatation Catheter for dilation of strictures in the airway tree.
The catheter is designed to pass over a 0.035-inch guidewire or through a bronchoscope working channel at least 2.8 millimeters wide.
Positioning Features
Two radiopaque tantalum marker bands sit within the balloon shoulders as fluoroscopic reference points for positioning the balloon in a stricture. The component list includes a tip, balloon, marker band, inner and outer tubes, hub, protective sheath and mandrel.
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 | Dongguan TT Medical, Inc., China |
|---|---|
| FDA product code | KTI |
| Device type | Bronchoscope Accessory |
| Device class | Class 2 |
| Regulation | 21 CFR 874.4680 |
| Establishment | Manufacturer |
| 510(k) | K222187 |
| Record published | 2025-02-10 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MSW-1230-09 | In distribution | |
| MSW-1830-09 | In distribution | |
| MSO-0830-09 | In distribution | |
| MSO-1230-09 | In distribution | |
| MSW-1255-09 | In distribution | |
| MSW-1855-09 | In distribution | |
| MSW-1030-09 | In distribution | |
| MSO-1255-09 | In distribution | |
| MSW-1530-09 | In distribution | |
| MSO-1030-09 | In distribution | |
| MSW-0630-09 | In distribution | |
| MSW-1055-09 | In distribution | |
| MSO-1530-09 | In distribution | |
| MSO-1555-09 | In distribution | |
| MSO-0855-09 | In distribution | |
| MSO-1055-09 | In distribution | |
| MSO-0630-09 | In distribution | |
| MSO-0655-09 | In distribution | |
| MSO-1830-09 | In distribution | |
| MSW-0655-09 | In distribution | |
| MSW-1555-09 | In distribution | |
| MSW-0855-09 | In distribution | |
| MSW-0830-09 | In distribution | |
| MSO-1855-09 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Bronchoscope Accessory | Richard Wolf Gmbh | 42 |
| 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 |
| Compass Steerable Needle | Serpex Medical, Inc. | 2 |
Showing 12 of 37. All products under Bronchoscope Accessory
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K222187 | 2023-03-01 |
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.