FDA device listing
Occlutech® ASD Occluder,Occlutech® Pistol Pusher
FDA device listing 1964490018 · Set Medikal Sanayi Ve Ticaret Anonim Sirketi
Key facts
| Proprietary names | Occlutech® ASD Occluder,Occlutech® Pistol Pusher |
|---|---|
| Owner/operator | Set Medikal Sanayi Ve Ticaret Anonim Sirketi |
| Owner/operator number | 10079852 |
| Product codes | OZG |
| Device names | OZG - Transcatheter Septal Occluder (Atrial) |
| Device class | Class III |
| Classification regulations (21 CFR) | ORCA1.OZG |
| Review panels | Cardiovascular |
| Registered establishments | SET MEDIKAL SANAYI VE TICARET ANONIM SIRKETI |
| Establishment registrations | 3017907716 |
| FEI numbers | 3017907716 |
| Establishment operations | Contract Sterilizer |
| 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