Cardiofocus, Inc.
Medical device manufacturer in Marlborough, MA.
5510(k) clearances
1PMA approvals
1recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K152310 | HeartLight Deflectable SheathDRA · Traditional | 02/24/2016SE |
| K013201 | Cardiofocus Diode Laser System, Models 60R, 60NR, 30NRGEX · Traditional | 03/18/2002SE |
| K013901 | Malleable Surgical Lightstic 180, Model 180 (1CM-9CM)GEX · Special | 12/20/2001SE |
| K011988 | Surgical Lightstic 180, Model 180 L, Model 180 COCL · Traditional | 09/20/2001SE |
| K993834 | Surgical Lightstic, Models, 180 L, and 180 CGEX · Traditional | 02/04/2000SE |
PMA approvals
- P150026 Heartlight Endoscopic Ablation System · 04/01/2016 · 15 supplements
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1307-2025 Class II | CardiFocus Heartlight X3 Catheter- Intended in the treatment of atrial fibrillation. It…Damage to the sterile barrier pouch of catheter, which could potentially compromise its sterility. | 02/07/2025Open, Classified |