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FDA 510(k)

Reprocessed PentaRay Nav eco High-Density Mapping Catheter

K-Number: K190785 · 2019-06-25

ApplicantInnovative Health, LLC
Decision Date2019-06-25
Product CodeNLG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Reprocessed PentaRay Nav eco High-Density Mapping Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Innovative Health, LLC. It received FDA 510(k) clearance on 2019-06-25 under 510(k) number K190785. The device is classified under product code NLG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Reprocessed PentaRay Nav eco High-Density Mapping Catheter?

Reprocessed PentaRay Nav eco High-Density Mapping Catheter is a medical device that received FDA 510(k) clearance on 2019-06-25. The listed applicant is Innovative Health, LLC. The 510(k) number is K190785.

When did Reprocessed PentaRay Nav eco High-Density Mapping Catheter receive FDA 510(k) clearance?

Reprocessed PentaRay Nav eco High-Density Mapping Catheter received FDA 510(k) clearance on 2019-06-25, under 510(k) number K190785.

Who is the listed applicant for Reprocessed PentaRay Nav eco High-Density Mapping Catheter?

The FDA 510(k) record lists Innovative Health, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Reprocessed PentaRay Nav eco High-Density Mapping Catheter?

The FDA product code for Reprocessed PentaRay Nav eco High-Density Mapping Catheter is NLG.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT06931821Functional ElectroAnatomiC Isochronal Late Activation Mapping for Empiric VT Ablation TrialRECRUITINGNCT07116525A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping CatheterRECRUITINGNCT07563257Comparative Evaluation of Optrell and Octaray Mapping Catheters for Conduction Block Confirmation and Voltage Assessment During Atrial AblationRECRUITINGNCT06808217A Registry on the FARAVIEW Technology of the OPAL HDx Mapping System When Used With the FARAWAVE NAV Ablation Catheter in the Treatment of Atrial FibrillationACTIVE_NOT_RECRUITING

Other records listing Innovative Health, LLC as applicant

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Related Devices (Code: NLG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K212776Reprocessed Advisor HD Grid Mapping Catheter, Sensor EnabledInnovative Health, LLCK211662Reprocessed IntellaMap Orion High Resolution Mapping CatheterInnovative Health, LLC

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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