FDA device listing
ILLUMISITE Bronchoscope Adapter Fujinon,ILLUMISITE Bronchoscope Adapter Olympus,ILLUMISITE Bronchoscope Adapter Olympus…
FDA device listing 1167910401 · Medtronic, Inc.
Key facts
| Proprietary names | ILLUMISITE Bronchoscope Adapter Fujinon,ILLUMISITE Bronchoscope Adapter Olympus,ILLUMISITE Bronchoscope Adapter Olympus 190,ILLUMISITE Bronchoscope Adapter Pentax,ILLUMISITE Console,ILLUMISITE Endobronchial Procedure Kit 180 Catheter,ILLUMISITE Endobronchial Procedure Kit 45 Catheter,ILLUMISITE Endobronchial Procedure Kit 90 Catheter,ILLUMISITE Patient Sensor Patch |
|---|---|
| Owner/operator | Medtronic, Inc. |
| Owner/operator number | 2112641 |
| Premarket submissions | K191394 |
| Product codes | JAK |
| Device names | JAK - System, X-Ray, Tomography, Computed |
| Device class | Class II |
| Classification regulations (21 CFR) | 892.1750 |
| Review panels | Radiology |
| Registered establishments | Medtronic Engineering and Innovation Center (MEIC) |
| Establishment registrations | 3018094310 |
| FEI numbers | 3018094310 |
| Establishment operations | Complaint File Establishment |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 10–99 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