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510(k) Data Aggregation
K Number
K213584Device Name
Reprocessed NRG Transseptal Needle
Manufacturer
Innovative Health, LLC.
Date Cleared
2023-04-04
(508 days)
Product Code
QLZ, OLZ, REP
Regulation Number
870.5175Why did this record match?
Product Code :
QLZ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Reprocessed NRG Transseptal Needle is used to create an atrial septal defect in the heart. Secondary indications include monitoring intracardiac pressures, sampling blood, and infusing solutions.
Device Description
The reprocessed NRG Transseptal Needle delivers radiofrequency (RF) power in a monopolar mode between its distal electrode and a commercially available Disposable Indifferent (Dispersive) Patch (DIP) Electrode, which is in compliance with IEC 60601-2-2. The NRG Transseptal Needle is loaded through a Transseptal Sheath/Dilator set and is connected at its proximal end to the BMC Radiofrequency Puncture Generator via the BMC Connector Cable and optionally to an external pressure monitoring system via a luer connection. The dimensions for the reprocessed NRG Transseptal Needle can be found on the device label. The distal end of the needle contains a hole to facilitate injection of contrast solution and the monitoring of cardiac pressures. As well, the active tip is specially shaped to be atraumatic to the cardiac tissue unless RF energy is applied.
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K Number
K200060Device Name
Reprocessed NRG Transseptal Needle
Manufacturer
Innovative Health, LLC.
Date Cleared
2020-07-30
(199 days)
Product Code
QLZ, OLZ
Regulation Number
870.5175Why did this record match?
Product Code :
QLZ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Reprocessed NRG Transseptal Needle is used to create an atrial septal defect in the heart. Secondary indications include monitoring intracardiac pressures, sampling blood, and infusing solutions.
Device Description
The reprocessed NRG Transseptal Needle delivers radiofrequency (RF) power in a monopolar mode between its distal electrode and a commercially available Disposable Indifferent (Dispersive) Patch (DIP) Electrode. The NRG Transseptal Needle is loaded through a Transseptal Sheath/Dilator set and is connected at its proximal end to the BMC Radiofrequency Puncture Generator via the BMC Connector Cable and, optionally, to an external pressure monitoring system via a luer connection.
The distal end of the needle contains a hole to facilitate injection of contrast solution and the monitoring of cardiac pressures. The active tip is specially shaped to be atraumatic to the cardiac tissue unless RF energy is applied.
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