Rapide(TM) Multistage Dilatation Balloon Catheter
the balloon diameter is 12-13.5-15mm, the balloon length is 80mm, the catheter diameter is 6 Fr., the working length is 1800mm, multistage dilation balloon catheter
9manufacturers in China registered for this device type
12catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (8), Zhejiang (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Changzhou Health Microport Medical Device Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 10 |
| Changzhou Jiuhong Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 10 |
| Jiangsu Changmei Medtech Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 8 |
| Micro-Tech (Nanjing) Co., Ltd. | Nan Jing | Jiangsu | Contract manufacturer | 49 |
| Jiangsu Vedkang Medical Science and Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 20 |
| Hangzhou AGS MedTech Co., Ltd. | Hangzhou | Zhejiang | Repacker / relabeller | 19 |
| Jiangsu Grit Medical Technology Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 13 |
| Jiangsu Power-Endo Medical Technology Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 7 |
| LEO Medical Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 4 |
Record
| Listed by | Micro-Tech (Nanjing) Co., Ltd., China |
|---|---|
| FDA product code | KNQ |
| Device type | Dilator, Esophageal |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5365 |
| Establishment | Contract manufacturer, Contract steriliser, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-12-31 |
| Record revised | 2025-12-01 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Box of 10, case of 10, box of 2, case of 25 |
| Sizes | Balloon diameter 6 to 20 mm; balloon length 8 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FWB-18/80-6/18-M | Balloon Diameter 18 mm | In distribution |
| FWB-12/80-6/18-M | Balloon Diameter 12 mm | In distribution |
| FWB-06/80-6/18-M | Balloon Diameter 6 mm | In distribution |
| FWB-15/80-6/18-M | Balloon Diameter 15 mm | In distribution |
| FWB-12/80-6/18-M | Balloon Diameter 12 mm | In distribution |
| FWB-15/80-6/18-M | Balloon Diameter 15 mm | In distribution |
| FWB-08/80-6/18-M | Balloon Diameter 8 mm | In distribution |
| FWB-10/80-6/18-M | Balloon Diameter 10 mm | In distribution |
| FWB-18/80-6/18-M | Balloon Diameter 18 mm | In distribution |
| FWB-10/80-6/18-M | Balloon Diameter 10 mm | In distribution |
| FWB-08/80-6/18-M | Balloon Diameter 8 mm | In distribution |
| FWB-06/80-6/18-M | Balloon Diameter 6 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Disposable Dilation Balloon | Micro-Tech (Nanjing) Co., Ltd. | 99 |
| Reliant(TM) Multistage Dilatation Balloon Catheter | Micro-Tech (Nanjing) Co., Ltd. | 37 |
| Quantum TTC | Cook Incorporated | 27 |
| Savary Gilliard | Cook Incorporated | 26 |
| SafeGuide® | Diversatek Healthcare Inc | 25 |
| Eliminator | ConMed Corporation | 21 |
| ABC Dilatation Balloon Catheter | Micro-Tech (Nanjing) Co., Ltd. | 21 |
| Flex-Ez Over the Wire Balloon Dilator | Hobbs Medical, Inc. | 19 |
| Flex-Ez Stylet Wire Balloon Dilator | Hobbs Medical, Inc. | 19 |
| Elation 5™ | Merit Medical Systems, Inc. | 18 |
| SafeGuide® Single | Diversatek Healthcare Inc | 16 |
| Conmed CleanGuide | Jiangsu Grit Medical Technology Co., Ltd. | 16 |
Showing 12 of 40. All products under Dilator, Esophageal
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.