# Cardiofocus, Inc.

- Location (FDA's records): Norton, MA
- FDA decisions: 6 (2000–2016): 5 510(k) clearances and 1 original PMA approval
- Product codes: GEX (3), OCL (1), DRA (1), OAE (1)
- Predicates its devices cite: 5 (2 its own); citations of its devices by later devices: 8 (2 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Ceram Optec, Inc.: 1 (https://510kreport.com/company/ceram-optec)
- Cryomedical Sciences, Inc.: 1 (https://510kreport.com/company/cryomedical-sciences)
- Medtronic Cryocath, LP: 1 (https://510kreport.com/company/medtronic-cryocath)

## Firms that cite its devices most
- Epicor Medical, Inc.: 3 (https://510kreport.com/company/epicor-medical)
- Medical, Inc.: 2 (https://510kreport.com/company/medical)
- Edwards Lifesciences, LLC: 1 (https://510kreport.com/company/edwards-lifesciences)

## Its most-cited devices
- K013901: Malleable Surgical Lightstic 180, Model 180 (1CM-9CM) (2001), cited by 4
- K011988: Surgical Lightstic 180, Model 180 L, Model 180 C (2001), cited by 2
- K013201: Cardiofocus Diode Laser System, Models 60R, 60NR, 30NR (2002), cited by 1
- K993834: Surgical Lightstic, Models, 180 L, and 180 C (2000), cited by 1

## Recent decisions
- P150026: Heartlight Endoscopic Ablation System (Apr 1, 2016)
- K152310: HeartLight Deflectable Sheath (Feb 24, 2016)
- K013201: Cardiofocus Diode Laser System, Models 60R, 60NR, 30NR (Mar 18, 2002)
- K013901: Malleable Surgical Lightstic 180, Model 180 (1CM-9CM) (Dec 20, 2001)
- K011988: Surgical Lightstic 180, Model 180 L, Model 180 C (Sep 20, 2001)
- K993834: Surgical Lightstic, Models, 180 L, and 180 C (Feb 4, 2000)

Source page: https://510kreport.com/company/cardiofocus