DK Medical Technology Co., Ltd.
Manufacturer and brand owner in Suzhou, Jiangsu, China. 3 device types, 4 products catalogued, 3 clearances.
DK Medical Technology Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Catheter, Percutaneous, Catheter, Percutaneous, Cutting/Scoring and 1 other device type. 4 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2023.
3device types registered with the FDA
4products catalogued under its own name
3510(k) clearances
Registration
| Status | Registered |
|---|---|
| Registration expires | 2026 |
| Registration number | 3027343398 |
| FEI number | 3027343398 |
| DUNS | 544100893 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 苏州鼎科医疗技术股份有限公司 |
|---|---|
| Unified social credit code | 91320594346302401E |
| Source | NMPA UDI database |
Location
| City | Suzhou |
|---|---|
| Province | Jiangsu |
| Address | Unit301, 303,305 and 311 bioBAY B1 Building, 218 Xinghu Str., Suzhou Industrial Park, Suzhou, Jiangsu, 215123 |
| Postal code | 215123 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Catheter, Angioplasty, Peripheral, Transluminal | Class 2 | PTA High Pressure Balloon Dilatation Catheter | 2023 | 5 |
| Catheter, Percutaneous | Class 2 | PTA High Pressure Balloon Dilatation Catheter | 2023 | 14 |
| Catheter, Percutaneous, Cutting/Scoring | Class 2 | Peripheral Scoring Balloon Dilatation Catheter, D·Kutting™ PTA Scoring Balloon Dilatation Catheter | 2024 | 3 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| PTA High Pressure Balloon Dilatation Catheter | LIT | 186 |
| PTA Scoring Balloon Dilatation Catheter | PNO | 120 |
| Peripheral Scoring Balloon Dilatation Catheter | PNO | 11 |
| PTA High Pressure Balloon Dilatation Catheter | DQY | 3 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K242254 | 2025-04-21 | PNO | Traditional | This company |
| K232207 | 2024-03-07 | PNO | Traditional | This company |
| K214009 | 2023-04-05 | LIT | Traditional | This company |
Nearby Manufacturers
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.
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