FDA device listing
lntellaTip MiFi™ Reference Cable Non-Sterile
FDA device listing 1907079227 · Nissha Medical Technologies
Key facts
| Proprietary names | lntellaTip MiFi™ Reference Cable Non-Sterile |
|---|---|
| Owner/operator | Nissha Medical Technologies |
| Owner/operator number | 9002200 |
| Product codes | OAD |
| Device names | OAD - Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
| Device class | Class III |
| Classification regulations (21 CFR) | ORCA1.OAD |
| Review panels | Cardiovascular |
| Registered establishments | CEA Medical Manufacturing, Inc. |
| Establishment registrations | 1721983 |
| FEI numbers | 1000064530 |
| Establishment operations | Contract Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database