FDA Device Establishments · JSON-LD · Markdown
FEI 3014368660 · Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device · Status: Active
| FEI Number | 3014368660 |
|---|---|
| Owner / Operator | CathRx (#10084686) |
| Address | Unit 8, 2-8 South St, Rydalmere New South Wales, 2116, AU |
| Mandatory US Agent | Acorn N Oakes LLC |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | DRF |
| Regulation § (21 CFR) | 870.1220 |
| Proprietary names | Khelix Fixed Electrophysiology Catheter; Khelix Fixed Loop Steerable Electrophysiology Catheters; Khelix Variable Loop Steerable Electrophysiology Catheters; Khelix Loop Electrophysiology Catheter; Khelix Steerable Electrophysiology Catheter |
Source: openFDA. Public-domain (CC0).