FDA Registration
Active
🇺🇸 United States
Adelante Destino Steerable Guiding Sheath
Reg #: 1035166
·
FEI: 1035166
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- OSCOR INC.
- Registration Number
- 1035166
- FEI Number
- 1035166
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 4875 Palm Harbor Blvd
- City
- PALM HARBOR
- State
- FL
- ZIP
- 34683
- Country
- US
Regulatory Submissions
- 510(k) Number
- K122960
Owner / Operator
- Firm Name
- OSCOR INC.
- Operator Number
- 1035166
- Address
- 4875 Palm Harbor Blvd, --
- City
- Palm Harbor
- State
- FL
- Postal Code
- 34683
- Country
- US
- Correspondent
- Ronnie - Greco
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Introducer, Catheter | DYB | Class 2 | Cardiovascular | No | 2013-03-25 |
Proprietary Names
Adelante Destino Steerable Guiding Sheath
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device