FDA Registration
Active
🇺🇸 United States
CPS Direct SL II Slittable Outer Catheter Models - DS2C007, DS2C017
Reg #: 2938836
·
FEI: 2938836
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Abbott Medical
- Registration Number
- 2938836
- FEI Number
- 2938836
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 645 Almanor Ave
- City
- Sunnyvale
- State
- CA
- ZIP
- 94085
- Country
- US
Regulatory Submissions
- 510(k) Number
- K103250
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 |
|---|---|---|---|---|---|
| Catheter, Percutaneous | DQY | Class 2 | Cardiovascular | No | 2013-02-25 |
Proprietary Names
CPS Direct SL II Slittable Outer Catheter Models - DS2C007, DS2C017
Establishment Types
Complaint File Establishment per 21 CFR 820.198