FDA Registration
Active
🇺🇸 United States
esolution
Reg #: 3019622578
·
FEI: 3019622578
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- S4 MEDICAL CORP
- Registration Number
- 3019622578
- FEI Number
- 3019622578
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 34 S Main St, Suite 200
- City
- Chagrin Falls
- State
- OH
- ZIP
- 44022
- Country
- US
Regulatory Submissions
- 510(k) Number
- DEN230006
Owner / Operator
- Firm Name
- S4 Medical Corp
- Operator Number
- 10082158
- Address
- 549 E Washington St, First Floor
- City
- Chagrin Falls
- State
- OH
- Postal Code
- 44022
- Country
- US
- Correspondent
- William Fuller
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Esophageal Protection Device For Use In Percutaneous Cardiac Catheter Ablation Procedures, Mechanical Deviation | QXU | Class 2 | Cardiovascular | No | 2024-06-13 |
Proprietary Names
esolution
Establishment Types
Manufacture Medical Device