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FDA 510(k)

Reprocessed PentaRay Nav eco High-Density Mapping Catheter

K-Number: K201806 · 2021-06-23

ApplicantSterilmed Inc. (Johnson and Johnson)
Decision Date2021-06-23
Product CodeMTD
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 Sterilmed Inc. (Johnson and Johnson). It received FDA 510(k) clearance on 2021-06-23 under 510(k) number K201806. The device is classified under product code MTD. 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 2021-06-23. The listed applicant is Sterilmed Inc. (Johnson and Johnson). The 510(k) number is K201806.

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 2021-06-23, under 510(k) number K201806.

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

The FDA 510(k) record lists Sterilmed Inc. (Johnson and Johnson) 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 MTD.

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

Related Devices (Code: MTD)

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.

K261012OptiMap Catheter - 60mm (OPTI-CATH2-60)Cortex, Inc.K253205OptiMap Catheter - 50mm (OPTI-CATH2-50)Cortex, Inc.K233433Sphere-9Dx Diagnostic Catheter (AFR-00009)MedtronicK241372Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™ABBOTT MEDICALK231312PENTARAY® NAV ECO High Density Mapping Catheter, DECANAV® Mapping Catheter, Webster® CS Catheter with Auto ID, Webster® CS Catheter with EZ Steer Technology, Webster® CS Catheter with EZ Steer Technology with Auto IDBiosense Webster, Inc.K223666Ablacath™ Mapping CatheterAblacon, Inc.

Official Source

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

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