FDA Registration
Active
🇺🇸 United States
Preface Guiding Sheath
Reg #: 3013300026
·
FEI: 3013300026
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- BIOSENSE WEBSTER, INC.
- Registration Number
- 3013300026
- FEI Number
- 3013300026
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 31 Technology Drive, Suite 200, --
- City
- Irvine
- State
- CA
- ZIP
- 92618
- Country
- US
Regulatory Submissions
- 510(k) Number
- K001139
Owner / Operator
- Firm Name
- BIOSENSE WEBSTER, INC.
- Operator Number
- 9044811
- Address
- 31 Technology Drive, Suite 200, --
- City
- Irvine
- State
- CA
- Postal Code
- 92618
- Country
- US
- Correspondent
- Maria Jose Arana
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Introducer, Catheter | DYB | Class 2 | Cardiovascular | No | 2007-11-28 |
Proprietary Names
Preface Guiding Sheath
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility