FDA device listing
Sub-Assembly, Cannula, RCSP, Gundry, Silicone, w/ Manual Inflating MR20 Ridged Cuff, Guidewire Stylet,13…
FDA device listing 1683575870 · Viant Medical, LLC
Key facts
| Proprietary names | Sub-Assembly, Cannula, RCSP, Gundry, Silicone, w/ Manual Inflating MR20 Ridged Cuff, Guidewire Stylet,13 FR,Sub-Assembly, Cannula, RCSP, Silicone, with Manual Inflating Elongated Smooth Cuff, Solid Stylet, 15 FR,Sub-Assembly, Cannula, RCSP, Silicone, with Manual Inflating MR20 Ridged Cuff, Guidewire Style Stylet, 15 FR,Sub-Assembly, Cannula, RCSP, Silicone, w/ Manual Inflating Elongated Smooth… |
|---|---|
| Owner/operator | Viant Medical, LLC |
| Owner/operator number | 9043339 |
| Product codes | DWF |
| Device names | DWF - Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Device class | Class II |
| Classification regulations (21 CFR) | 870.4210 |
| Review panels | Cardiovascular |
| Registered establishments | Viant Costa Rica, S.A. |
| Establishment registrations | 3005173255 |
| FEI numbers | 3005173255 |
| 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