Catheter, Intracardiac Mapping, High-Density Array
FDA product code MTD · 32 cleared devices
Class 2
Cardiovascular
- Regulation
- 21 CFR 870.1220
- Review panel
- CV
- Implant
- No
- Life sustaining
- No
- Third party review
- No
- GMP exempt
- No
- Clearance span
- 1999-01-27 – 2026-04-23
MTD
2026-04-23
MTD
2026-03-13
OptiMap Catheter - 50mm (OPTI-CATH2-50)
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MTD
2024-08-07
Sphere-9Dx Diagnostic Catheter (AFR-00009)
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MTD
2024-07-09
Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™
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MTD
2023-07-10
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
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MTD
2023-03-17
Ablacath™ Mapping Catheter
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MTD
2023-03-02
OPTRELL™ Mapping Catheter with TRUEref™ Technology
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MTD
2022-06-21
AcQMap 3D Imaging and Mapping Catheter, Model 900009
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MTD
2022-03-18
OPTRELL Mapping Catheter with TRUEref Technology
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MTD
2021-06-23
Reprocessed PentaRay Nav eco High-Density Mapping Catheter
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MTD
2020-09-15
AcQMap 3D Imaging and Mapping Catheter
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MTD
2020-09-03
Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled
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MTD
2020-08-06
Pentaray Nav eco High-Density Mapping Catheter
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MTD
2020-07-31
Carto Octaray Mapping Catheter with Trueref Technology
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MTD
2018-04-23
Advisor HD Grid Mapping Catheter, Sensor Enabled
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MTD
2017-10-16
AcQMap 3D Imaging and Mapping Catheter
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MTD
2017-02-28
FIRMap Catheter
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MTD
2016-04-07
FIRMap Catheter
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MTD
2013-10-31
FIRMAP CATHETER
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MTD
2013-03-05
PENTARAY NAV ECO HIGH-DENSITY MAPPING CATHETER
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MTD
2012-05-24
PENTARAY NAV HIGH-DENSITY MAPPING CATHETER
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MTD
2012-05-03
ENSITE ARRAY MULTI-ELECTRODE DIAGNOSTIC CATHETER
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MTD
2005-03-30
FLOWER HIGH-DENSITY MAPPING CATHETER, 4-4-4 MM ELECTRODE SPACING), (2-6-2 MM ELECTRODE SPACING)
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MTD
2002-05-16
CONSTELLATION CATHETERS, MODEL 8031M
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MTD
2001-09-28
MODIFICATION TO ENSITE 3000 SYSTEM, MODEL EE3000
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MTD
2001-02-14
CONSTELLATION CATHETER, MODEL 8031
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MTD
2000-09-26
CONSTELLATION CATHETERS
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MTD
1999-11-12
CONSTELLATION CATHETERS, MODEL 8039
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MTD
1999-06-08
MERCATOR ATRIAL HIGH DENSITY ARRAY CATHETER; CARDIAC PATHWAYS EGM ADAPTER CABLES
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MTD
1999-04-21
ENSITE 3000 SYSTEM
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MTD
1999-03-11
CONSTELLATION MULTIPLE ELECTRODE PACING AND RECORDING SYSTEM
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MTD
1999-01-27
MERCATOR ATRIAL HIGH DENSITY ARRAY CATHETER MODELS, 7005, 7006, 7007, MERCATOR ATRIAL HIGH DENSITY ARRAY DEPLOYMENT KIT,
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