Ablacath™ Mapping Catheter
by Ablacon Inc.
510(k) K223666
Ablacath™ Mapping Catheter is a Class II device made by Ablacon Inc., cleared under FDA 510(k) K223666 on 17 Mar 2023, active as of 25 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK223666 | Date17 Mar 2023 | StatusActive |
Official records
- FDA 510(k) database K223666
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- MTD
- FDA applicant
- Ablacon, Inc.
- Device class
- Class II
- Regulation
- 21 CFR Part 870.1220
- Advisory committee
- Cardiovascular
- FDA decision
- SESE Substantially Equivalent
Similar devices
Other devices filed under FDA product code MTD (Catheter, Intracardiac Mapping, High-Density Array).
- Advisor HD Grid Mapping Catheter, Sensor Enabled by ST. JUDE MEDICAL, INC.
- AcQMap 3D Imaging and Mapping Catheter, Model 900009 by Acutus Medical, Inc.
- MODIFICATION TO ENSITE 3000 SYSTEM, MODEL EE3000 by Endocardial Solutions, Inc.
- PENTARAY NAV ECO HIGH-DENSITY MAPPING CATHETER by Biosense Webster Inc
- OPTRELL™ Mapping Catheter with TRUEref™ Technology by Biosense Webster Inc
- Reprocessed PentaRay Nav eco High-Density Mapping Catheter by Sterilmed Inc. (Johnson and Johnson)
- ENSITE ARRAY MULTI-ELECTRODE DIAGNOSTIC CATHETER by ST. JUDE MEDICAL, INC.
- MERCATOR ATRIAL HIGH DENSITY ARRAY CATHETER MODELS, 7005, 7006, 7007, MERCATOR ATRIAL HIGH DENSITY ARRAY DEPLOYMENT KIT, by Cardiac Pathways Corp.
- FIRMap Catheter by Abbott Electrophysiology
- ENSITE 3000 SYSTEM by Endocardial Solutions, Inc.