FDA Device Establishments · JSON-LD · Markdown
FEI 3007048256 · Export Device to the United States But Perform No Other Operation on Device · Status: Active
| FEI Number | 3007048256 |
|---|---|
| Owner / Operator | Quasar Engineering Ltd. (#10025822) |
| Address | Flat B1, 10/F, Yeung Yiu Chung No.6 Industrial Bldg, 19 Cheung Shun St, Cheung Sha Wan, Kowloon, NONE, HK |
| Mandatory US Agent | Registrar Corp. |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | MCW |
| Regulation § (21 CFR) | 870.4875 |
| Proprietary names | Auryon Atherectomy System OR Auryon Atherecomy Catheter |
Source: openFDA. Public-domain (CC0).