FDA device listing
Coaxial Cable Cryoconsole ECG Cable Freezor cardiac cryoablation catheter Freezor MAX Surgical cryoablation cathete
FDA device listing 1013475824 · DSV Contract Logistics
Key facts
| Proprietary names | Coaxial Cable Cryoconsole ECG Cable Freezor cardiac cryoablation catheter Freezor MAX Surgical cryoablation cathete |
|---|---|
| Owner/operator | DSV Contract Logistics |
| Owner/operator number | 10095650 |
| Premarket submissions | P020045 |
| Product codes | LPB |
| Device names | LPB - Cardiac Ablation Percutaneous Catheter |
| Device class | Class III |
| Classification regulations (21 CFR) | ORCA1.LPB |
| Review panels | Cardiovascular |
| Registered establishments | DSV CONTRACT LOGISTICS |
| Establishment registrations | 3044156918 |
| FEI numbers | 3044156918 |
| Establishment operations | Foreign Exporter |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 100–999 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