FDA Registration
Active
🇺🇸 United States
INTRICON CORPORATION
Reg #: 2134850
·
FEI: 3003007876
·
Expires 2026
Products
7
Proprietary Names
6
Establishment Types
2
Classifications
7
Registration Details
- Registration Name
- INTRICON CORPORATION
- Registration Number
- 2134850
- FEI Number
- 3003007876
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1260 Red Fox Rd
- City
- ARDEN HILLS
- State
- MN
- ZIP
- 55112
- Country
- US
Regulatory Submissions
- 510(k) Number
- K151236
- PMA Number
- P980022
Owner / Operator
- Firm Name
- INTRICON CORPORATION
- Operator Number
- 9039676
- Address
- 1265 Grey Fox Road, --
- City
- Saint Paul
- State
- MN
- Postal Code
- 55112
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, X-Ray, Tomography, Computed | JAK | Class 2 | Radiology | No | 2023-02-10 |
| Insulin Pump Secondary Display | PKU | Class 2 | Clinical Chemistry | No | 2015-12-10 |
| Continuous Glucose Monitor Secondary Display | PJT | Class 2 | Clinical Chemistry | No | 2015-12-10 |
| Automated Insulin Dosing Device System, Single Hormonal Control | OZP | Class 3 | Unknown | No | 2019-11-22 |
| Automated Insulin Dosing , Threshold Suspend | OZO | Class 3 | Unknown | No | 2017-01-23 |
| Sensor, Glucose, Invasive | MDS | Class 3 | Unknown | No | 2020-05-08 |
| Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor | OYC | Class 3 | Unknown | No | 2013-01-11 |
Proprietary Names
Percutaneous Biopsy Needle
Electromagnetic Tracker
Endobronchial Guidewire
Flexible Biopsy Needle
Percutaneous Localization Needle
Endobronchial Biopsy Brush
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device