Selethru(TM) NC PTCA Balloon Dilatation Catheter — Kossel Medtech (Suzhou) Co., Ltd. (510(k) K211393)
Selethru(TM) NC PTCA Balloon Dilatation Catheter — Kossel Medtech (Suzhou) Co., Ltd. (510(k) K211393) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: Selethru(TM) NC PTCA Balloon Dilatation Catheter; Applicant: Kossel Medtech (Suzhou) Co., Ltd.; Clearance track: 510(k).
| Device name | Selethru(TM) NC PTCA Balloon Dilatation Catheter |
|---|---|
| Applicant | Kossel Medtech (Suzhou) Co., Ltd. |
| Clearance track | 510(k) |
| Submission number | K211393 |
| Decision | Substantially Equivalent |
| Decision date | 2021-07-02 |
| Date received | 2021-05-05 |
| Product code | LOX |
| Device class | 2 |
| Medical specialty | Cardiovascular |
| Applicant location | CN |
| Source | openFDA device |
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