Is this your brand? Sign in to claim ownership.

Cardiofocus, Inc.

United States·US-MF-000008457

Last updated September 17, 2026

Information

Device	Model / Reference	Registries	Class	Status
HeartLight	18-1447	FDA UDI	Class III	Active
HeartLight	18-4000-27A	FDA UDI	Class III	Active
HeartLight	18-5000	FDA UDI	Class III	Active
HeartLight	18-1342	FDA UDI	Class III	Active
HeartLight	18-4247	FDA UDI	Class III	Active
HeartLight	18-3356	FDA UDI	Class II	Active
HeartLight	18-4952	FDA UDI	Class III	Active
HeartLight	18-5033	FDA UDI	Class III	Active
HeartLight	CF980-E10-US	FDA UDI	Class III	Active
HeartLight	18-2531-N250	FDA UDI	Class III	Active
HeartLight	18-4957	FDA UDI	Class III	Active
HeartLight	18-2959	FDA UDI	Class III	Active
Surgical Lightstic 180, Model 180 L, Model 180 C	K011988	FDA 510(k)	Class II	Active
Cardiofocus Diode Laser System, Models 60r, 60nr, 30nr	K013201	FDA 510(k)	Class II	Active
Surgical Lightstic, Models, 180 L, And 180 C	K993834	FDA 510(k)	Class II	Active
HeartLight Deflectable Sheath	K152310	FDA 510(k)	Class II	Active
Malleable Surgical Lightstic 180, Model 180 (1cm-9cm)	K013901	FDA 510(k)	Class II	Active
WAVE1 Activation Materials	GTI-00036	EUDAMED	Class IIb	Active
Centauri Connect	GTI-00022-03	EUDAMED	Class I	Active
HeartLight System	P150026	FDA PMA	Class III	Active

Not available yet.

Not available yet.

Not available yet.

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Feb 7, 2025	Z-1307-2025	—	open, classified	Damage to the sterile barrier pouch of catheter, which could potentially compromise its sterility.