FDA Registration
Active
🇺🇸 United States
Peel Away Introducer kit replacement syringe accessory Models 405104, 405108, 405112, 405116, 405118, 405119, 405120, 40
Reg #: 2017865
·
FEI: 2017865
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ABBOTT MEDICAL
- Registration Number
- 2017865
- FEI Number
- 2017865
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 15900 Valley View Court
- City
- Sylmar
- State
- CA
- ZIP
- 91342
- Country
- US
Regulatory Submissions
- 510(k) Number
- K230283
Owner / Operator
- Firm Name
- ABBOTT LABORATORIES
- Operator Number
- 1415939
- Address
- 100 ABBOTT PARK RD., D-03Q3, AP52-1
- City
- Abbott Park
- State
- IL
- Postal Code
- 60064
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Introducer, Catheter | DYB | Class 2 | Cardiovascular | No | 2023-03-08 |
Proprietary Names
Peel Away Introducer kit replacement syringe accessory Models 405104, 405108, 405112, 405116, 405118, 405119, 405120, 40
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility