FDA Registration
Active
🇺🇸 United States
ClearPath Nasal Balloon System
Reg #: 3012422952
·
FEI: 3012422952
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- INTUIT MEDICAL PRODUCTS, LLC
- Registration Number
- 3012422952
- FEI Number
- 3012422952
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1990 Riverside Parkway
- City
- Lawrenceville
- State
- GA
- ZIP
- 30043
- Country
- US
Regulatory Submissions
- 510(k) Number
- K181546
Owner / Operator
- Firm Name
- Intuit Medical Products, LLC
- Operator Number
- 10050055
- Address
- 1990 Riverside Parkway
- City
- Lawrenceville
- State
- GA
- Postal Code
- 30043
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Instrument, Ent Manual Surgical | LRC | Class 1 | Ear, Nose, Throat | No | 2020-02-20 |
Proprietary Names
ClearPath Nasal Balloon System
ClearPath Nasal Balloon Catheter
Establishment Types
Repack or Relabel Medical Device
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility