| Primary Device ID | 06972253606312 |
| NIH Device Record Key | ef9b2ee1-9d67-46f8-97cd-7d7203916ddd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PTA Scoring Balloon Dilatation Catheter |
| Version Model Number | DKT35-6080A |
| 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 |