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FDA 510(k)

CRF Radiofrequency Ablation System

K-Number: K192715 · 2020-01-07

ApplicantCambridge Interventional, LLC
Decision Date2020-01-07
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CRF Radiofrequency Ablation System is a medical device manufactured by Cambridge Interventional, LLC. It received FDA 510(k) clearance on 2020-01-07 under approval number K192715. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CRF Radiofrequency Ablation System?

CRF Radiofrequency Ablation System is a medical device that received FDA 510(k) clearance on 2020-01-07. It is manufactured by Cambridge Interventional, LLC. The 510(k) number is K192715.

When was CRF Radiofrequency Ablation System approved by the FDA?

CRF Radiofrequency Ablation System received FDA 510(k) clearance on 2020-01-07, under approval number K192715.

What company makes CRF Radiofrequency Ablation System?

CRF Radiofrequency Ablation System is manufactured by Cambridge Interventional, LLC.

What is the FDA product code for CRF Radiofrequency Ablation System?

The FDA product code for CRF Radiofrequency Ablation System is GEI.

Related Clinical Trials

NCT07137455 EDEN Intracardiac Electrogram Recording and Classifying System ENROLLING_BY_INVITATION NCT06762717 FARAPULSE™ Pulsed Field Ablation System RECRUITING NCT06170606 POLARx Post Approval Study (POLARx PAS) ACTIVE_NOT_RECRUITING NCT06510556 Feasibility Study of the FARAFLEX Mapping and PFA System RECRUITING NCT06735534 Repeat Ablation of Persistent Atrial Fibrillation, Including Mitral Isthmus Catheter Ablation, With the FARAPULSE Pulsed Field Ablation System RECRUITING NCT05685134 Epicardial Radiofrequency Catheter Ablation in Patients With Brugada Syndrome COMPLETED

Related PubMed Literature

PMID: 36632328 Integrating real-world data to assess cardiac ablation device outcomes in a multicenter study using the OMOP common data model for regulatory decisions: implementation and evaluation. JAMIA open (2023)

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Official Source

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