| Primary Device ID | 06923533807912 |
| NIH Device Record Key | e21291ce-ee75-4b3d-bc34-c5765c7af3cb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PTA High Pressure Balloon Dilatation Catheter |
| Version Model Number | HPA50-3040A5 |
| Company DUNS | 544100893 |
| Company Name | DK Medical Technology Co., Ltd. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |