FDA Registration
Active
🇺🇸 United States
ILLUMISITE Bronchoscope Adapter Fujinon
Reg #: 3004962788
·
FEI: 3004962788
·
Expires 2025
Products
1
Proprietary Names
9
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- Covidien llc
- Registration Number
- 3004962788
- FEI Number
- 3004962788
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 161 CHESHIRE LANE, SUITE 100
- City
- Plymouth
- State
- MN
- ZIP
- 55441
- Country
- US
Regulatory Submissions
- 510(k) Number
- K191394
Owner / Operator
- Firm Name
- Covidien llc
- Operator Number
- 1282497
- Address
- 15 HAMPSHIRE STREET, --
- City
- Mansfield
- State
- MA
- Postal Code
- 02048
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, X-Ray, Tomography, Computed | JAK | Class 2 | Radiology | No | 2019-09-18 |
Proprietary Names
ILLUMISITE Bronchoscope Adapter Fujinon
ILLUMISITE Bronchoscope Adapter Pentax
ILLUMISITE Bronchoscope Adapter Olympus 190
ILLUMISITE Bronchoscope Adapter Olympus
ILLUMISITE Patient Sensor Patch
ILLUMISITE Endobronchial Procedure Kit 90 Catheter
ILLUMISITE Console
ILLUMISITE Endobronchial Procedure Kit 45 Catheter
ILLUMISITE Endobronchial Procedure Kit 180 Catheter
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device