Data / Medical devices / China / DK Medical Technology Co., Ltd.
DK Medical Technology Co., Ltd.: FDA-registered device maker in Suzhou Jiangsu, China, 3 510(k) clearances
DK Medical Technology Co., Ltd. is registered with the FDA (registration 3027343398) in Suzhou Jiangsu, China. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated April 21, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3027343398
- Address
- Unit301, 303,305 and 311 bioBAY B1 Building, 218 Xinghu Str., Suzhou Industrial Park, Suzhou, Jiangsu, 215123 #5 Building, #9 Suhong West Rd., Suzhou, Jiangsu, China; Block A7, No. 56 Yangfu Rd, Suzhou, Jiangsu, China, Suzhou Jiangsu, China, 215123
- Owner or operator
- DK Medical Technology Co., Ltd. (10087839)
- Roles
- Manufacturer
- First device listed
- April 17, 2023
- Registered through
- 2026
- Brand names listed
- D·Kutting PTA Scoring Balloon Dilatation Catheter, PTA High Pressure Balloon Dilatation Catheter, Peripheral Scoring Balloon Dilatation Catheter
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Angioplasty, Peripheral, Transluminal | LIT | 2 | Manufacturer | accessdata.fda.gov |
| Catheter, Percutaneous | DQY | 2 | Manufacturer | accessdata.fda.gov |
| Catheter, Percutaneous, Cutting/Scoring | PNO | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 21, 2025 | K242254 | D·Kutting LL Peripheral Scoring Balloon Dilatation Catheter | PNO | Substantially Equivalent | Dk Medical Technology Co., Ltd. | accessdata.fda.gov |
| March 7, 2024 | K232207 | D·Kutting PTA Scoring Balloon Dilatation Catheter | PNO | Substantially Equivalent | Dk Medical Technology Co., Ltd. | accessdata.fda.gov |
| April 5, 2023 | K214009 | D·Kaptain PTA High Pressure Balloon Dilatation Catheter | LIT | Substantially Equivalent | Dk Medical Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Catheter, Percutaneous, Cutting/Scoring
- All makers of Catheter, Angioplasty, Peripheral, Transluminal
- All makers of Catheter, Percutaneous
Updated April 21, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.