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510(k) Data Aggregation
K Number
K233900Device Name
Nordica PV Cryo Mapping Catheter
Manufacturer
Synaptic Medical Corporation
Date Cleared
2024-09-06
(270 days)
Product Code
DRF
Regulation Number
870.1220Why did this record match?
Applicant Name (Manufacturer) :
Synaptic Medical Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Nordica PV Cryo Mapping Catheter is indicated for multiple electrophysiological mapping of cardiac structures (i.e., recording and stimulation only). The Nordica PV Cryo Mapping Catheter is designed to obtain electrograms in the atrial regions of the heart.
Device Description
The Nordica PV Cryo Mapping Catheter is a 3F sterile, single use, multi-electrode, diagnostic catheter designed to map cardiac signals during ablation procedures. The catheter is provided with a fixed loop diameter of 15mm or 20mm with either 5 or 4 evenly spaced, radiopaque pairs of electrodes. The proximal end of the catheter contains an electrical connection for the EP electrical cable that integrates with electrophysiology lab recording systems. Once deployed in the vasculature through the central lumen of a catheter, a circular or spiral shape is established such that the electrodes contact the endocardial surface. This allows for recording, pacing, and interrogation of electrical conduction between the left atrium and the pulmonary veins.
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K Number
K240246Device Name
Accusafe Transseptal Guidewire (GTR31180, GTR31230)
Manufacturer
Synaptic Medical Corporation
Date Cleared
2024-07-26
(178 days)
Product Code
DRC
Regulation Number
870.1390Why did this record match?
Applicant Name (Manufacturer) :
Synaptic Medical Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K233708Device Name
NaviGo 12F Steerable Intracardiac Catheter Introducer Kit (S12FS-01)
Manufacturer
Synaptic Medical Corporation
Date Cleared
2024-02-16
(88 days)
Product Code
DYB
Regulation Number
870.1340Why did this record match?
Applicant Name (Manufacturer) :
Synaptic Medical Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The NaviGo 12F Steerable Intracardiac Catheter Introducer Kit is intended to introduce various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.
Device Description
The NaviGo 12F Steerable Intracardiac Catheter Introducer Kit consists of a 1) Steerable Sheath, 2) Dilator and 3) Guidewire, and is indicated for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum. When the left side of the heart is accessed, the device is used with a compatible Transseptal Needle to puncture the interatrial septum for transseptal catheterization procedures. The NaviGo 12F Steerable Intracardiac Catheter Introducer Kit is a sterile, single use device, with asymmetrical bi-directional steerable introducer with usable length of 65cm. The Steerable Sheath is fitted with a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. A side port with three-way stopcock is provided for air or blood aspiration, fluid infusion, blood sampling, and pressure monitoring. The handle is equipped with a rotating collar to deflect the Steerable Sheath tip clockwise ≥ 180° and counterclockwise ≥ 90°. The steerable introducer features distal vent holes to facilitate aspiration and a radiopaque tip marker to improve fluoroscopic visualization.
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K Number
K203793Device Name
RithmID-SD Steerable Diagnostic Electrophysiology Catheter
Manufacturer
Synaptic Medical Corporation
Date Cleared
2022-02-14
(413 days)
Product Code
DRF
Regulation Number
870.1220Why did this record match?
Applicant Name (Manufacturer) :
Synaptic Medical Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The RithmID-SD Steerable Diagnostic Electrophysiology Catheter can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites.
Device Description
The RithmID-SD Steerable Diagnostic Electrophysiology Catheter are biocompatible, flexible, radiopaque electrophysiology catheters that are available in a variety of diameters, lengths, curve shapes, and electrode number and spacing configurations, with a high-torque shaft with an array of platinum iridium alloy electrodes at the distal tip that can be used for recording electrical signals. The catheter is designed to facilitate the electrophysiological mapping of the heart.
The RithmID-SD Steerable Diagnostic Electrophysiology Catheter consist of a handle, a shaft and a steerable diagnostic tip. The catheter is introduced through the sheath and into the femoral vein, from the inferior vena cava into the heart and coronary sinus. The RithmID-SD Steerable Diagnostic Electrophysiology Catheter are available in 6F in various curves, including B, D, Y, and R curves.
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