FDA Registration
Active
🇺🇸 United States
CLEAR GUIDE MEDICAL
Reg #: 3011396687
·
FEI: 3011396687
·
Expires 2026
Products
7
Proprietary Names
12
Establishment Types
2
Classifications
7
Registration Details
- Registration Name
- CLEAR GUIDE MEDICAL
- Registration Number
- 3011396687
- FEI Number
- 3011396687
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 3600 Clipper Mill Rd Ste 400
- City
- Baltimore
- State
- MD
- ZIP
- 21211
- Country
- US
Regulatory Submissions
- 510(k) Number
- K201188
Owner / Operator
- Firm Name
- Clear Guide Medical
- Operator Number
- 10048333
- Address
- 3600 Clipper Mill Road, Suite 400
- City
- Baltimore
- State
- MD
- Postal Code
- 21211
- Country
- US
- Correspondent
- Patrick T Duke
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, X-Ray, Tomography, Computed | JAK | Class 2 | Radiology | No | 2020-10-08 |
| System, X-Ray, Film Marking, Radiographic | JAC | Class 1 | Radiology | No | 2016-03-09 |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | Class 2 | Radiology | No | 2014-12-30 |
| Introducer, Catheter | DYB | Class 2 | Cardiovascular | No | 2015-07-20 |
| Drape, Surgical, Exempt | PUI | Class 2 | General, Plastic Surgery | No | 2019-11-08 |
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2024-12-30 |
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2024-12-30 |
Proprietary Names
SCENERGY
Clear Guide VisiMARKER
Clear Guide TipTAG
Clear Guide VisiMARKER II
Clear Guide ONE
Clear Guide SCENERGY
VisiTIP B-Bevel Needle (VT1820B)
VisiTIP B-Bevel Needle (VT2010B)
SteriMASK
Clear Guide SteriGRID
Clear Guide SCENERGY TP
Clear Guide TP Access Tool
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Repack or Relabel Medical Device