Data / Medical devices / China / Kossel Medtech (suzhou) Co., Ltd.
Kossel Medtech (suzhou) Co., Ltd.: FDA-registered device maker in Suzhou Jiangsu, China, 6 510(k) clearances
Kossel Medtech (suzhou) Co., Ltd. is registered with the FDA (registration 3014390222) in Suzhou Jiangsu, China. It lists 4 device types. The FDA files 6 510(k) clearances under its listings, the newest dated October 15, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014390222
- Address
- Building 6, No.8 Jinfeng Road, Suzhou New District, Jiangsu, 215163, China, Suzhou Jiangsu, China, 215163
- Owner or operator
- Kossel Medtech (Suzhou) Co., Ltd. (10061920)
- Roles
- Manufacturer
- First device listed
- December 3, 2019
- Registered through
- 2026
- Brand names listed
- Falexpand HP PTA Balloon Dilatation Catheter, Falspeed PTA Balloon Dilatation Catheter, Selebrek PTCA Balloon Dilatation Catheter, Selepump Inflation Device, Selestem Radial Artery Tourniquet, Selethru NC PTCA Balloon Dilatation Catheter, Selethru PTCA Balloon Dilatation Catheter
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Angioplasty, Peripheral, Transluminal | LIT | 2 | Manufacturer | accessdata.fda.gov |
| Catheters, Transluminal Coronary Angioplasty, Percutaneous | LOX | 2 | Manufacturer | accessdata.fda.gov |
| General Use Pneumatic Tourniquet | QGX | 1 | Manufacturer | accessdata.fda.gov |
| Syringe, Balloon Inflation, Exempt | PTM | 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 |
|---|---|---|---|---|---|---|
| October 15, 2026 | K262674 | Giranel Guiding Sheath Set | DYB | Substantially Equivalent | Kossel Medtech (Suzhou) Co., Ltd. | accessdata.fda.gov |
| December 20, 2023 | K231402 | HP PTA Balloon Dilatation Catheter | LIT | Substantially Equivalent | Kossel Medtech (Suzhou) Co., Ltd. | accessdata.fda.gov |
| December 14, 2022 | K221245 | PTA Balloon Dilatation Catheter | LIT | Substantially Equivalent | Kossel Medtech (Suzhou) Co., Ltd. | accessdata.fda.gov |
| January 7, 2022 | K211349 | Selebrek PTCA Balloon Dilatation Catheter | LOX | Substantially Equivalent | Kossel Medtech (Suzhou) Co., Ltd. | accessdata.fda.gov |
| July 2, 2021 | K211393 | Selethru(TM) NC PTCA Balloon Dilatation Catheter | LOX | Substantially Equivalent | Kossel Medtech (Suzhou) Co., Ltd. | accessdata.fda.gov |
| November 26, 2018 | K182699 | Selethru PTCA Balloon Dilatation Catheter | LOX | Substantially Equivalent | Kossel Medtech (Suzhou) Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Catheter, Angioplasty, Peripheral, Transluminal
- All makers of Catheters, Transluminal Coronary Angioplasty, Percutaneous
- All makers of Syringe, Balloon Inflation, Exempt
- All makers of General Use Pneumatic Tourniquet
Updated October 15, 2026. 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.