Atlas FDA

MTD

34 FDA 510(k) clearances · Product code

101 daysmedian time to decision
300 days90th percentile
34clearances measured

FDA profile

Official device name
Catheter, Intracardiac Mapping, High-Density Array
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1220
Medical specialty
Cardiovascular
Adverse events (MAUDE)
2021: 99 · 2022: 145 · 2023: 184 · 2024: 378 · 2025: 394 · 2026: 207
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
OptiMap Catheter - 60mm (OPTI-CATH2-60) (K261012)Cortex, Inc.2026-04-23
OptiMap Catheter - 50mm (OPTI-CATH2-50) (K253205)Cortex, Inc.2026-03-13
Sphere-9Dx Diagnostic Catheter (AFR-00009) (K233433)Medtronic2024-08-07
Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™ (K241372)ABBOTT MEDICAL2024-07-09
PENTARAY® NAV ECO High Density Mapping Catheter, DECANAV® Mapping Catheter, Webster® CS Catheter with Auto ID, Webster® CS Catheter with EZ Steer Technology, Webster® CS Catheter with EZ Steer Technology with Auto ID (K231312)Biosense Webster, Inc.2023-07-10
Ablacath™ Mapping Catheter (K223666)Ablacon, Inc.2023-03-17
OPTRELL™ Mapping Catheter with TRUEref™ Technology (K230253)Biosense Webster, Inc.2023-03-02
AcQMap 3D Imaging and Mapping Catheter, Model 900009 (K210766)Acutus Medical, Inc.2022-06-21
OPTRELL Mapping Catheter with TRUEref Technology (K211438)Biosense Webster, Inc.2022-03-18
Reprocessed PentaRay Nav eco High-Density Mapping Catheter (K201806)Sterilmed Inc. (Johnson and Johnson)2021-06-23
AcQMap 3D Imaging and Mapping Catheter (K201341)Acutus Medical, Inc.2020-09-15
Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled (K200212)Innovative Health, LLC2020-09-03
Pentaray Nav eco High-Density Mapping Catheter (K201750)Biosense Webster, Inc.2020-08-06
Carto Octaray Mapping Catheter with Trueref Technology (K193237)Biosense Webster, Inc.2020-07-31
Advisor HD Grid Mapping Catheter, Sensor Enabled (K172393)St. Jude Medical, Inc.2018-04-23
AcQMap 3D Imaging and Mapping Catheter (K170819)Acutus Medical, Inc.2017-10-16
FIRMap Catheter (K163709)Abbott Electrophysiology2017-02-28
FIRMap Catheter (K153093)Abbott Electrophysiology2016-04-07
FRIMAP ADAPTER CONNECTOR (MAC) (K142182)Topera, Inc.2014-09-09
CONSTELLATION MULTIPLE ELECTRODE RECORDING & PACING CATHETER (K140733)Boston Scientific Corporation2014-04-28
FIRMAP CATHETER (K130827)Topera, Inc.2013-10-31
PENTARAY NAV ECO HIGH-DENSITY MAPPING CATHETER (K123837)Biosense Webster, Inc.2013-03-05
PENTARAY NAV HIGH-DENSITY MAPPING CATHETER (K120425)Biosense Webster, Inc.2012-05-24
ENSITE ARRAY MULTI-ELECTRODE DIAGNOSTIC CATHETER (K121006)St Jude Medical2012-05-03
FLOWER HIGH-DENSITY MAPPING CATHETER, 4-4-4 MM ELECTRODE SPACING), (2-6-2 MM ELECTRODE SPACING) (K050217)Biosense Webster, Inc.2005-03-30
CONSTELLATION CATHETERS, MODEL 8031M (K021232)Boston Scientific Corp2002-05-16
MODIFICATION TO ENSITE 3000 SYSTEM, MODEL EE3000 (K012926)Endocardial Solutions, Inc.2001-09-28
CONSTELLATION CATHETER, MODEL 8031 (K003782)Boston Scientific Corp2001-02-14
CONSTELLATION CATHETERS (K000277)Boston Scientific Corp2000-09-26
CONSTELLATION CATHETERS, MODEL 8039 (K992777)Boston Scientific Corp1999-11-12
MERCATOR ATRIAL HIGH DENSITY ARRAY CATHETER; CARDIAC PATHWAYS EGM ADAPTER CABLES (K990795)Cardiac Pathways Corp.1999-06-08
ENSITE 3000 SYSTEM (K983456)Endocardial Solutions, Inc.1999-04-21
CONSTELLATION MULTIPLE ELECTRODE PACING AND RECORDING SYSTEM (K983171)Boston Scientific Corp1999-03-11
MERCATOR ATRIAL HIGH DENSITY ARRAY CATHETER MODELS, 7005, 7006, 7007, MERCATOR ATRIAL HIGH DENSITY ARRAY DEPLOYMENT KIT, (K982540)Cardiac Pathways Corp.1999-01-27

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Every clearance here is in the API, with alerts when new ones post.