PTA High Pressure Balloon Dilatation Catheter

3 catalogue numbers from HPA75-7080B5, listed by DK Medical Technology Co., Ltd., China, under Catheter, Percutaneous. 14 manufacturers in China are registered for this product code.

Registry build 21.09.26
14manufacturers in China registered for this device type
3catalogue numbers in this listing

Who Else Makes It

Concentrated in Shanghai (5), Jiangsu (5), Guangdong (3). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code DQY
Manufacturer City Province Registered as Device types
Jabil Circuit (Shanghai) Ltd. Shanghai Shanghai Contract manufacturer 31
Covidien Medical Products (Shanghai) Manufacturing LLC Shanghai Shanghai Contract manufacturer 8
Sterigenics Shanghai ETO Ltd. Shanghai Shanghai Contract manufacturer 65
Steris Sterilization Technologies (Suzhou) Ltd Suzhou Jiangsu Contract manufacturer 44
Goals Sterilization Co., Ltd. Jiaxing Zhejiang Contract manufacturer 26
Wuxi Goals Medical Technology Co., Ltd. Yixing Jiangsu Contract manufacturer 24
Suzhou Zenith Vascular Scitech Limited Suzhou Jiangsu Manufacturer 6
Haolang Technology (Foshan) Limited Corporation Foshan Guangdong Contract manufacturer 6
OrbusNeich Medical (Shenzhen) Co., Ltd. Shenzhen Guangdong Complaint-file establishment 5
Curatia Medical Limited Suzhou Jiangsu Specification developer 5
Shanghai Wallaby Medical Technologies Co., Inc. Shanghai Shanghai Contract manufacturer 5
DK Medical Technology Co., Ltd. Suzhou Jiangsu Manufacturer 3

Showing 12 of 14. All 14 manufacturers in China registered for Catheter, Percutaneous

Record

Regulatory record for PTA High Pressure Balloon Dilatation Catheter
Listed by DK Medical Technology Co., Ltd., China
FDA product code DQY
Device type Catheter, Percutaneous
Device class Class 2
Regulation 21 CFR 870.1250
Establishment Manufacturer
510(k) K214009
Record published 2025-07-16

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Label carries lot or batch number, expiry date, manufacturing date

Catalogue Numbers

Catalogue numbers for PTA High Pressure Balloon Dilatation Catheter
Catalogue number Size Status
HPA75-7080B5 In distribution
HPA75-60100B5 In distribution
HPA130-7020C5 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Launcher™ Medtronic, Inc. 3,805
Sherpa NX Balanced™ Medtronic, Inc. 1,523
Arrow Teleflex Medical LLC 1,249
Z2 Medtronic, Inc. 955
Vista Brite TIP Cordis Corp. 789
Mach1™ Boston Scientific Corporation 777
Sherpa NX Active Medtronic, Inc. 571
Zuma® Medtronic, Inc. 569
Convey Pendracare International B.V. 532
Taiga Medtronic, Inc. 307
RunWay™ Boston Scientific Corporation 300
ConcierGE Guiding Excellence™ Merit Medical Systems, Inc. 295

Showing 12 of 500. All products under Catheter, Percutaneous

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