Company ยท US
Cardiofocus, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2000 to 2016. Name variants (Inc, Corp, punctuation) are merged.
5510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 24, 2016 | K152310 | HeartLight Deflectable Sheath Cardiofocus, Inc. | DRA |
| Mar 18, 2002 | K013201 | CARDIOFOCUS DIODE LASER SYSTEM, MODELS 60R, 60NR, 30NR Cardiofocus, Inc. | GEX |
| Dec 20, 2001 | K013901 | MALLEABLE SURGICAL LIGHTSTIC 180, MODEL 180 (1CM-9CM) Cardiofocus, Inc. | GEX |
| Sep 20, 2001 | K011988 | SURGICAL LIGHTSTIC 180, MODEL 180 L, MODEL 180 C Cardiofocus, Inc. | OCL |
| Feb 4, 2000 | K993834 | SURGICAL LIGHTSTIC, MODELS, 180 L, AND 180 C Cardiofocus, Inc. | GEX |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 10, 2025 | CardioFocus, Inc. CardiFocus Heartlight X3 Catheter- Intended in the treatment of atrial fibrillation. It is
introduced percutaneously in the setting of an Electrophysiology or Catheterization Laboratory
Model: 18-5000 Open, Classified |
OAE | None listed |