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FDA 510(k)

Nordica PV Cryo Mapping Catheter

K-Number: K233900 · 2024-09-06

ApplicantSynaptic Medical Corporation
Decision Date2024-09-06
Product CodeDRF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Nordica PV Cryo Mapping Catheter is a medical device manufactured by Synaptic Medical Corporation. It received FDA 510(k) clearance on 2024-09-06 under approval number K233900. The device is classified under product code DRF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Nordica PV Cryo Mapping Catheter?

Nordica PV Cryo Mapping Catheter is a medical device that received FDA 510(k) clearance on 2024-09-06. It is manufactured by Synaptic Medical Corporation. The 510(k) number is K233900.

When was Nordica PV Cryo Mapping Catheter approved by the FDA?

Nordica PV Cryo Mapping Catheter received FDA 510(k) clearance on 2024-09-06, under approval number K233900.

What company makes Nordica PV Cryo Mapping Catheter?

Nordica PV Cryo Mapping Catheter is manufactured by Synaptic Medical Corporation.

What is the FDA product code for Nordica PV Cryo Mapping Catheter?

The FDA product code for Nordica PV Cryo Mapping Catheter is DRF.

Related Clinical Trials

NCT01254474 Evaluation of Depolarization and Repolarisation Activity During Cardiac Arrhythmia Using a Novel Monophasic Action Potential Catheter COMPLETED NCT06510556 Feasibility Study of the FARAFLEX Mapping and PFA System RECRUITING NCT03053141 RHythmia mAPping and Signal acquisitiOn for Data analYsis (RHAPSODY) RECRUITING NCT05225935 Computed Tomography-Guided Catheter Ablation for Ventricular Tachycardia COMPLETED NCT07308847 Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360) RECRUITING NCT06808217 A Registry on the FARAVIEW Technology of the OPAL HDx Mapping System When Used With the FARAWAVE NAV Ablation Catheter in the Treatment of Atrial Fibrillation ACTIVE_NOT_RECRUITING

Other Devices by Synaptic Medical Corporation

K203793RithmID-SD Steerable Diagnostic Electrophysiology Catheter K240246Accusafe Transseptal Guidewire (GTR31180, GTR31230) K233708NaviGo 12F Steerable Intracardiac Catheter Introducer Kit (S12FS-01)

Related Devices (Code: DRF)

K160335Advisor FL 15mm 12 Pole 333 Uni D, Advisor FL 20mm 12 Pole 555 Uni D, Advisor FL 15mm 12 Pole 333 Bi D, Advisor FL 20mm 12 Pole 555 Bi DSt Jude Medical K161769Reprocessed Supreme Diagnostic Electrophysiology CathetersInnovative Health, LLC K162892Achieve Advance Mapping CatheterMedtronic, Inc. K151139EasyMap MAP CatheterMedfact Engineering GmbH K153139Achieve ST Mapping Catheter, Catheter Connecting CableMedtronic, Inc. K160390Map-it Diagnostic Mapping CathetersAccess Point Technologies Ep, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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