FDA device listing
Python OTW Embolectomy Catheter
FDA device listing 1157571248 · LEMAITRE VASCULAR, INC.
Key facts
| Proprietary names | Python OTW Embolectomy Catheter |
|---|---|
| Owner/operator | LEMAITRE VASCULAR, INC. |
| Owner/operator number | 1220948 |
| Premarket submissions | K970762 |
| Product codes | DXE |
| Device names | DXE - Catheter, Embolectomy |
| Device class | Class II |
| Classification regulations (21 CFR) | 870.5150 |
| Review panels | Cardiovascular |
| Registered establishments | LeMaitre Vascular Inc., LEMAITRE VASCULAR, INC. |
| Establishment registrations | 1220948, 3045042524 |
| FEI numbers | 1220948, 3045042524 |
| Establishment operations | Manufacturer |
| 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