Abbott Electrophysiology
FDA Regulatory Profile
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 4
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2478-2015 | Class III | FIRMap 60mm Catheter; Size: 60 mm; Length 50.4 inches French Size Diameter: 8.5F (2.84mm) Model n | August 12, 2015 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K171583 | RhythmView Workstation | September 1, 2017 |
| K163709 | FIRMap Catheter | February 28, 2017 |
| K161240 | Rhythm View Workstation (non-streaming) | August 10, 2016 |
| K153093 | FIRMap Catheter | April 7, 2016 |