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510(k) Data Aggregation
K Number
K212776Device Name
Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled
Manufacturer
Innovative Health, LLC.
Date Cleared
2021-12-20
(110 days)
Product Code
NLG
Regulation Number
870.1220Why did this record match?
Product Code :
NLG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled, is indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart, i.e., recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart.
Device Description
The Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled, is an irrigated steerable, flexible, insulated electrophysiology catheter constructed of thermoplastic elastomer material and noble metal electrodes. The shaft curvature is manipulated by the control mechanism located on the handle at the catheter's proximal end. To adjust the curve on the catheter, use the actuator to deflect the catheter in either direction. The catheter is compatible with St. Jude Medical (Abbott) visualization and 3D navigation systems.
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K Number
K211662Device Name
Reprocessed IntellaMap Orion High Resolution Mapping Catheter
Manufacturer
Innovative Health, LLC.
Date Cleared
2021-11-18
(170 days)
Product Code
NLG
Regulation Number
870.1220Why did this record match?
Product Code :
NLG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Reprocessed IntellaMap Orion High Resolution Mapping Catheter is indicated for electrophysiological mapping (recording or stimulating only) of the cardiac structures of the heart.
Device Description
The Reprocessed IntellaMap Orion High Resolution Mapping Catheter is an 8.5F(ø 2.82 mm), 115 cm working length, 64-electrode steerable catheter. The basket-shaped distal reqion consists of 8 splines that comprise the electrode array. The proximal end has a handle that extends to a cable with a connector. The handle includes bi-directional articulation controls and a deployment slider that activates the electrode array into a basket shape once inside the heart. A flushing port extends from the back of the connector for connection to a continuous pressurized saline drip. The catheter is supplied with an 8.5F insertion sleeve for insertion through the hemostasis valve of an introducer sheath. A sensor in the catheter tip enables the position of the distal region of the catheter to be tracked in space when used with the Rhythmia Mapping System.
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K Number
K190785Device Name
Reprocessed PentaRay Nav eco High-Density Mapping Catheter
Manufacturer
Innovative Health, LLC.
Date Cleared
2019-06-25
(90 days)
Product Code
NLG
Regulation Number
870.1220Why did this record match?
Product Code :
NLG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Reprocessed PentaRay Nav eco High-Density Mapping Catheter is indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart, i.e. recording or stimulation only. The catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart.
The catheter provides location information when used with the compatible Carto 3 EP Navigation Systems. (This catheter is not compatible with Carto 3 EP Navigation Systems prior to Version 3.x.)
Device Description
The Reprocessed PentaRay Nav eco High-Density Mapping Catheter is designed to facilitate electrophysiological mapping of the heart with the Carto 3 EP Navigation System. It is designed for deployment in a heart chamber through an 8 F guiding sheath. This deflectable catheter consists of multiple 3F spines on its distal tip, each spine having multiple platinum electrodes that are used for stimulation and recording. A magnetic location sensor embedded in the deflectable tip transmits location information to the Carto 3 EP Navigation System. The catheter has two electrodes on the deflectable tip to provide for visualization of the tip when used with the Carto 3 EP Navigation System. Pushing forward on the catheter thumb knob deflects the tip; pulling back on the thumb knob straightens the tip. This device includes an irrigation lumen for connection to a source of continuous anticoagulant fluid.
This catheter interfaces with standard recording equipment and the Carto 3 EP Navigation System via interface cables with the appropriate connectors.
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