FDA Registration
Active
🇺🇸 United States
Disposable Patient Cables
Reg #: 3005334138
·
FEI: 3005334138
·
Expires 2025
Products
1
Proprietary Names
9
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- St. Jude Medical, Cardiology Division, Inc.
- Registration Number
- 3005334138
- FEI Number
- 3005334138
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 5050 Nathan Lane North
- City
- Plymouth
- State
- MN
- ZIP
- 55442
- Country
- US
Regulatory Submissions
- 510(k) Number
- K910645
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 |
|---|---|---|---|---|---|
| Cable, Transducer And Electrode, Patient, (Including Connector) | DSA | Class 2 | Cardiovascular | No | 2007-12-11 |
Proprietary Names
Disposable Patient Cables
SJM Adapter
Cable Connectors
SJM Epicardial Cable 401777, 401778
SJM Patient Cable 401758,401759,401760
SJM Threshold Cable 401748
Abbott Medical Epicardial Cable
Abbott Medical Threshold Cable
Abbott Medical Patient Cable
Establishment Types
Complaint File Establishment per 21 CFR 820.198