FDA device listing
Heart Valve Sizer and Template,OZAKI AVNeo(R) Sizer (13, 15, 17),OZAKI AVNeo(R) Sizer (31, 33, 35),OZAKI AVNeo(R) Sizer…
FDA device listing 1255325542 · Sanamedi, Inc.
Key facts
| Proprietary names | Heart Valve Sizer and Template,OZAKI AVNeo(R) Sizer (13, 15, 17),OZAKI AVNeo(R) Sizer (31, 33, 35),OZAKI AVNeo(R) Sizer System,OZAKI VRec Sizer (13mm, 15mm, 17mm),OZAKI VRec Sizer System (19mm, 21mm, 23mm, 25mm, 27mm, 29mm, 31mm, 33mm, 35mm) |
|---|---|
| Owner/operator | Sanamedi, Inc. |
| Owner/operator number | 10046345 |
| Product codes | DTI |
| Device names | DTI - Sizer, Heart-Valve, Prosthesis |
| Device class | Class I |
| Classification regulations (21 CFR) | 870.3945 |
| Review panels | Cardiovascular |
| Registered establishments | Sanamedi, Inc. |
| Establishment registrations | 3010805418 |
| FEI numbers | 3010805418 |
| Establishment operations | Specification Developer |
| 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