CardioFocus, Inc.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 5
- Inspections
- 5
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-1307-2025 | Class II | CardiFocus Heartlight X3 Catheter- Intended in the treatment of atrial fibrillation. It is introduc | February 7, 2025 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K152310 | HeartLight Deflectable Sheath | February 24, 2016 |
| K013201 | CARDIOFOCUS DIODE LASER SYSTEM, MODELS 60R, 60NR, 30NR | March 18, 2002 |
| K013901 | MALLEABLE SURGICAL LIGHTSTIC 180, MODEL 180 (1CM-9CM) | December 20, 2001 |
| K011988 | SURGICAL LIGHTSTIC 180, MODEL 180 L, MODEL 180 C | September 20, 2001 |
| K993834 | SURGICAL LIGHTSTIC, MODELS, 180 L, AND 180 C | February 4, 2000 |