FDA device listing
Base Camp Sheath System 2.0 Berenstein 80cm,Base Camp Sheath System 2.0 Berenstein 90cm
FDA device listing 1327159028 · Route 92 Medical
Key facts
| Proprietary names | Base Camp Sheath System 2.0 Berenstein 80cm,Base Camp Sheath System 2.0 Berenstein 90cm |
|---|---|
| Owner/operator | Route 92 Medical |
| Owner/operator number | 10054934 |
| Premarket submissions | K240529 |
| Product codes | DQY, QJP |
| Device names | DQY - Catheter, Percutaneous, QJP - Catheter, Percutaneous, Neurovasculature |
| Device class | Class II |
| Classification regulations (21 CFR) | 870.1250 |
| Review panels | Cardiovascular |
| Registered establishments | Route 92 Medical, Head Quarters, Route 92 Medical, West Jordan |
| Establishment registrations | 3016522967, 3030088112 |
| FEI numbers | 3016522967, 3030088112 |
| Establishment operations | Complaint File Establishment, Manufacturer, Repackager/Relabeler |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes 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