FDA Registration
Active
🇺🇸 United States
CPS Direct SL II Slittable Outer Catheter
Reg #: 3013288201
·
FEI: 3013288201
·
Expires 2025
Products
1
Proprietary Names
4
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ABBOTT MEDICAL
- Registration Number
- 3013288201
- FEI Number
- 3013288201
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 14901 Deveau Pl. Building 2
- City
- Minnetonka
- State
- MN
- ZIP
- 55345
- Country
- US
Regulatory Submissions
- 510(k) Number
- K092075
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
DS2C001, DS2C002, DS2C003, DS2C004, DS2C005, DS2C006, DS2C011, DS2C012, DS2C013, DS2C014, DS2C015
CPS Universal Slitter Model DS2A003
CPS Universal II Slitter Model DS2A004
Establishment Types
Manufacture Medical Device