Cardiofocus, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Cardiofocus, Inc.” (first 2000, latest 2016), plus 1 PMA decision, across 4 product codes in 2 review panels. Median 510(k) review time under this name: 86 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 194 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | 3 | 3 |
| DRA | Catheter, Steerable | 1 | 1 |
| OAE | Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation | 1 | 0 |
| OCL | Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue | 1 | 1 |
Review panels
Most recent Cardiofocus, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K152310 | HeartLight Deflectable Sheath | DRA | 2016-02-24 | 194 |
| K013201 | CARDIOFOCUS DIODE LASER SYSTEM, MODELS 60R, 60NR, 30NR | GEX | 2002-03-18 | 174 |
| K013901 | MALLEABLE SURGICAL LIGHTSTIC 180, MODEL 180 (1CM-9CM) | GEX | 2001-12-20 | 24 |
| K011988 | SURGICAL LIGHTSTIC 180, MODEL 180 L, MODEL 180 C | OCL | 2001-09-20 | 86 |
| K993834 | SURGICAL LIGHTSTIC, MODELS, 180 L, AND 180 C | GEX | 2000-02-04 | 84 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P150026 | PMA | HEARTLIGHT ENDOSCOPIC ABLATION SYSTEM | 2016-04-01 |
Recalls
1 product recalls in 1 recall events; 1 initiated in the last five years. Most recent: 2025-02-07.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Cardiofocus, Inc. is the lead sponsor of 9 device studies on ClinicalTrials.gov (3 active or recruiting). Most recent:
- NCT06828939: Pulmonary Vein Isolation With the Single Shot Endoscopic Ultra-Compliant PFA Balloon for the Treatment of AF (Recruiting, started 2024-12-12)
- NCT07281521: Ablation With the PFA System With a Large-Area Focal Catheter for the Treatment of Persistent Atrial Fibrillation (Recruiting, started 2023-02-27)
- NCT03988244: HeartLight X3 Endoscopic Ablation System With Excalibur Balloon for Treatment of Symptomatic Persistent AF (Completed, started 2019-02-26)
- NCT03470636: Clinical Study of the HeartLight X3 Endoscopic Ablation System With Excalibur Balloon (Completed, started 2018-02-15)
- NCT03168659: CardioFocus HeartLight Post-Approval Study (Recruiting, started 2017-06-16)
Frequently asked questions
How many FDA 510(k) clearances are listed under Cardiofocus, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Cardiofocus, Inc.” (first 2000, latest 2016), plus 1 PMA decision, across 4 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Cardiofocus, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cardiofocus, Inc. is 86 days.
Which FDA product codes appear under Cardiofocus, Inc.?
The most frequent FDA product codes under this applicant name are GEX (Powered Laser Surgical Instrument, 3); DRA (Catheter, Steerable, 1); OAE (Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation, 1).
Next steps
- See all 5 Cardiofocus, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEX, Cardiofocus, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.