Disposable Dilation Balloon

the balloon diameter is 15mm, the balloon length is 55mm, the catheter diameter is 7 Fr., and the working length is 1800mm,with stainless steel guide wire

Registry build 21.09.26
9manufacturers in China registered for this device type
99catalogue 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.

Chinese manufacturers registered for FDA product code KNQ
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

Regulatory record for Disposable Dilation Balloon
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 2025-12-02 (version 5)

Specifications

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, case of 10
Sizes Balloon diameter 6 to 35 mm; balloon length 30 to 80 mm

Catalogue Numbers

Catalogue numbers for Disposable Dilation Balloon
Catalogue number Size Status
BDC-15/55-7/18-A Balloon Diameter 15 mm In distribution
BDC-26/80-7/24-A Balloon Diameter 26 mm In distribution
BDC-34/80-7/24-A Balloon Diameter 34 mm In distribution
BDC-14/80-7/18-A Balloon Diameter 14 mm In distribution
BDC-8/30-7/18-A Balloon Diameter 8 mm In distribution
BDC-15/55-7/24-A Balloon Diameter 15 mm In distribution
BDC-6/80-7/10-A Balloon Diameter 6 mm In distribution
BDC-10/30-7/10-A Balloon Diameter 10 mm In distribution
BDC-14/80-7/10-A Balloon Diameter 14 mm In distribution
BDC-18/30-7/18-A Balloon Diameter 18 mm In distribution
BDC-6/30-7/18-A Balloon Diameter 6 mm In distribution
BDC-30/80-7/10-A Balloon Diameter 30 mm In distribution
BDC-10/80-7/24-A Balloon Diameter 10 mm In distribution
BDC-10/80-7/18-A Balloon Diameter 10 mm In distribution
BDC-12/80-7/24-A Balloon Diameter 12 mm In distribution
BDC-18/30-7/10-A Balloon Diameter 18 mm In distribution
BDC-20/80-7/10-A Balloon Diameter 20 mm In distribution
BDC-25/80-7/24-A Balloon Diameter 25 mm In distribution
BDC-30/80-7/18-A Balloon Diameter 30 mm In distribution
BDC-8/55-7/24-A Balloon Diameter 8 mm In distribution
BDC-10/55-7/10-A Balloon Diameter 10 mm In distribution
BDC-15/30-7/10-A Balloon Diameter 15 mm In distribution
BDC-18/55-7/10-A Balloon Diameter 18 mm In distribution
BDC-26/80-7/10-A Balloon Diameter 26 mm In distribution
BDC-16/80-7/18-A Balloon Diameter 16 mm In distribution
BDC-12/55-7/24-A Balloon Diameter 12 mm In distribution
BDC-6/55-7/24-A Balloon Diameter 6 mm In distribution
BDC-30/80-7/24-A Balloon Diameter 30 mm In distribution
BDC-14/30-7/18-A Balloon Diameter 14 mm In distribution
BDC-8/80-7/24-A Balloon Diameter 8 mm In distribution
BDC-14/80-7/24-A Balloon Diameter 14 mm In distribution
BDC-18/80-7/10-A Balloon Diameter 18 mm In distribution
BDC-20/30-7/10-A Balloon Diameter 20 mm In distribution
BDC-12/55-7/10-A Balloon Diameter 12 mm In distribution
BDC-6/55-7/10-A Balloon Diameter 6 mm In distribution
BDC-35/80-7/18-A Balloon Diameter 35 mm In distribution
BDC-20/55-7/18-A Balloon Diameter 20 mm In distribution
BDC-20/80-7/18-A Balloon Diameter 20 mm In distribution
BDC-12/30-7/24-A Balloon Diameter 12 mm In distribution
BDC-6/80-7/18-A Balloon Diameter 6 mm In distribution
BDC-14/55-7/24-A Balloon Diameter 14 mm In distribution
BDC-16/30-7/10-A Balloon Diameter 16 mm In distribution
BDC-15/80-7/18-A Balloon Diameter 15 mm In distribution
BDC-18/55-7/24-A Balloon Diameter 18 mm In distribution
BDC-12/30-7/18-A Balloon Diameter 12 mm In distribution
BDC-8/30-7/10-A Balloon Diameter 8 mm In distribution
BDC-6/55-7/18-A Balloon Diameter 6 mm In distribution
BDC-16/55-7/10-A Balloon Diameter 16 mm In distribution
BDC-25/80-7/10-A Balloon Diameter 25 mm In distribution
BDC-20/55-7/24-A Balloon Diameter 20 mm In distribution
BDC-16/30-7/18-A Balloon Diameter 16 mm In distribution
BDC-6/40-7/24-A Balloon Diameter 6 mm In distribution
BDC-34/80-7/10-A Balloon Diameter 34 mm In distribution
BDC-6/80-7/24-A Balloon Diameter 6 mm In distribution
BDC-34/80-7/18-A Balloon Diameter 34 mm In distribution
BDC-8/30-7/24-A Balloon Diameter 8 mm In distribution
BDC-8/55-7/10-A Balloon Diameter 8 mm In distribution
BDC-35/80-7/10-A Balloon Diameter 35 mm In distribution
BDC-15/30-7/24-A Balloon Diameter 15 mm In distribution
BDC-18/30-7/24-A Balloon Diameter 18 mm In distribution
BDC-16/80-7/24-A Balloon Diameter 16 mm In distribution
BDC-20/80-7/24-A Balloon Diameter 20 mm In distribution
BDC-8/80-7/10-A Balloon Diameter 8 mm In distribution
BDC-14/30-7/10-A Balloon Diameter 14 mm In distribution
BDC-18/80-7/24-A Balloon Diameter 18 mm In distribution
BDC-10/30-7/24-A Balloon Diameter 10 mm In distribution
BDC-35/80-7/24-A Balloon Diameter 35 mm In distribution
BDC-10/30-7/18-A Balloon Diameter 10 mm In distribution
BDC-6/30-7/10-A Balloon Diameter 6 mm In distribution
BDC-26/80-7/18-A Balloon Diameter 26 mm In distribution
BDC-18/55-7/18-A Balloon Diameter 18 mm In distribution
BDC-15/80-7/10-A Balloon Diameter 15 mm In distribution
BDC-16/55-7/24-A Balloon Diameter 16 mm In distribution
BDC-10/80-7/10-A Balloon Diameter 10 mm In distribution
BDC-6/40-7/18-A Balloon Diameter 6 mm In distribution
BDC-16/55-7/18-A Balloon Diameter 16 mm In distribution
BDC-15/55-7/10-A Balloon Diameter 15 mm In distribution
BDC-8/55-7/18-A Balloon Diameter 8 mm In distribution
BDC-20/55-7/10-A Balloon Diameter 20 mm In distribution
BDC-6/30-7/24-A Balloon Diameter 6 mm In distribution
BDC-14/55-7/18-A Balloon Diameter 14 mm In distribution
BDC-12/80-7/10-A Balloon Diameter 12 mm In distribution
BDC-25/80-7/18-A Balloon Diameter 25 mm In distribution
BDC-8/80-7/18-A Balloon Diameter 8 mm In distribution
BDC-12/55-7/18-A Balloon Diameter 12 mm In distribution
BDC-15/80-7/24-A Balloon Diameter 15 mm In distribution
BDC-6/40-7/10-A Balloon Length 40 mm In distribution
BDC-20/30-7/24-A Balloon Diameter 20 mm In distribution
BDC-12/80-7/18-A Balloon Diameter 12 mm In distribution
BDC-15/30-7/18-A Balloon Diameter 15 mm In distribution
BDC-14/30-7/24-A Balloon Diameter 14 mm In distribution
BDC-18/80-7/18-A Balloon Diameter 18 mm In distribution
BDC-20/30-7/18-A Balloon Diameter 20 mm In distribution
BDC-16/30-7/24-A Balloon Diameter 16 mm In distribution
BDC-14/55-7/10-A Balloon Diameter 14 mm In distribution
BDC-12/30-7/10-A Balloon Diameter 12 mm In distribution
BDC-16/80-7/10-A Balloon Diameter 16 mm In distribution
BDC-10/55-7/24-A Balloon Diameter 10 mm In distribution
BDC-10/55-7/18-A Balloon Diameter 10 mm In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
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
Conmed ConMed Corporation 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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer