510(k) K150631
St. Jude Medical MediGuide Enabled Livewire Steerable Electroohysiology Catheter, Livewire Electrophysiology Catheter by
St Jude Medical
— Product Code DRF
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 1, 2015
- Date Received
- March 11, 2015
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Electrode Recording, Or Probe, Electrode Recording
- Device Class
- Class II
- Regulation Number
- 870.1220
- Review Panel
- CV
- Submission Type