FDA Registration
Active
🇺🇸 United States
I-Tek Medical, Inc.
Reg #: 3008627763
·
FEI: 3008627763
·
Expires 2026
Products
16
Proprietary Names
13
Establishment Types
4
Classifications
16
Registration Details
- Registration Name
- I-Tek Medical, Inc.
- Registration Number
- 3008627763
- FEI Number
- 3008627763
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1837 Buerkle Rd
- City
- White Bear Lake
- State
- MN
- ZIP
- 55110
- Country
- US
Regulatory Submissions
- 510(k) Number
- K210087
Owner / Operator
- Firm Name
- I-Tek Medical, Inc.
- Operator Number
- 10047604
- Address
- 1837 Buerkle Road
- City
- White Bear Lake
- State
- MN
- Postal Code
- 55110
- Country
- US
- Correspondent
- Patrick Haley
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Shield, Vial | IWW | Class 1 | Radiology | No | 2017-03-14 |
| System, Catheter Control, Steerable | DXX | Class 2 | Cardiovascular | No | 2014-10-10 |
| Wire, Guide, Catheter | DQX | Class 2 | Cardiovascular | No | 2014-10-10 |
| Dropper, Ent | KCM | Class 1 | Ear, Nose, Throat | No | 2026-05-19 |
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2022-09-16 |
| Gastroscope And Accessories, Flexible/Rigid | FDS | Class 2 | Gastroenterology, Urology | No | 2022-09-16 |
| Catheter, Percutaneous | DQY | Class 2 | Cardiovascular | No | 2014-10-10 |
| Catheter, Intravascular Occluding, Temporary | MJN | Class 2 | Cardiovascular | No | 2014-10-10 |
| Kit, Surgical Instrument, Disposable | KDD | Class 1 | General, Plastic Surgery | No | 2023-07-13 |
| Table And Attachments, Operating-Room | BWN | Class 1 | General, Plastic Surgery | No | 2026-02-11 |
| Marker, Radiographic, Implantable | NEU | Class 2 | General, Plastic Surgery | No | 2021-12-30 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2026-03-20 |
| Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator | OTN | Class 2 | General, Plastic Surgery | No | 2023-12-20 |
| Powered Laser Surgical Instrument | GEX | Class 2 | General, Plastic Surgery | No | 2014-10-10 |
| Neurological Stereotaxic Instrument | HAW | Class 2 | Neurology | No | 2014-10-10 |
| Retractor, Fiberoptic | FDG | Class 1 | Gastroenterology, Urology | No | 2014-10-10 |
Proprietary Names
Elution Test Vial Bottle use with CardioGen-82 Infusion Syst; Elution Test Vial Shield use with CardioGen-82 Infusion S
VDRIVE W/V-SONO
q50 plus stent graft balloon catheter18
Brekka
Stingray
SafeTuck
EnVisio Navigation System Navigator and Calibration Disk
ReActiv8 Release Tool
CARDIODRIVE CATHETER ADVANCEMENT SYSTEM (CAS)
Athena Surgical RMUS System
NEUROBLATE SYSTEM
I-Tek Fiber Optic Illuminator
VDRIVE WITH V-LOOP
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Complaint File Establishment per 21 CFR 820.198
Sterilize Medical Device for Another Party (Contract Sterilizer)
Manufacture Medical Device