Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter

K-Number: K233825 · 2024-06-07

ApplicantInnovative Health
Decision Date2024-06-07
Product CodeNLH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter is a medical device manufactured by Innovative Health. It received FDA 510(k) clearance on 2024-06-07 under approval number K233825. The device is classified under product code NLH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter?

Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter is a medical device that received FDA 510(k) clearance on 2024-06-07. It is manufactured by Innovative Health. The 510(k) number is K233825.

When was Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter approved by the FDA?

Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter received FDA 510(k) clearance on 2024-06-07, under approval number K233825.

What company makes Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter?

Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter is manufactured by Innovative Health.

What is the FDA product code for Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter?

The FDA product code for Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter is NLH.

Related Clinical Trials

NCT07595666 Comparison of NeuroEXPLORER PET/CT Versus Standard-of-care PET/CT of the Head and Neck Region. ENROLLING_BY_INVITATION NCT07471308 P-wave Duration and Local Potential as Predictors of AF Recurrence Following Pulmonary Vein Isolation ACTIVE_NOT_RECRUITING NCT07539701 An Initial Experience With the Disposable Celsio Cryocatheter System for Diagnostic and Interventional Bronchoscopy NOT_YET_RECRUITING NCT06556836 "Diagnostic Accuracy of Ultrasound Compared to Epidurography for Epidural Catheter Localization" COMPLETED

Related PubMed Literature

PMID: 40969652 Risk-sharing agreements for medical devices: a stakeholder-based qualitative study in Czechia. Frontiers in public health (2025)

Other Devices by Innovative Health

K250305Reprocessed Agilis NxT Steerable Introducer

Related Devices (Code: NLH)

K162251Reprocessed Viking Diagnostic Electrophysiology CathetersInnovative Health, LLC K161827Reprocessed Response Diagnostic Electrophysiology CathetersInnovative Health, LLC K160421Reprocessed Inquiry Optima Plus Steerable Diagnostic EP Catheter, Reprocessed Inquiry Optima Steerable Diagnostic EP CatheterInnovative Health, LLC K161393Reprocessed Orbiter ST Steerable Diagnostic EP CatheterInnovative Health, LLC K161464Reprocessed Dynamic Tip Steerable Diagnostic Electrophysiology CathetersInnovative Health, LLC K153006Reprocessed Lasso NAV eco and Lasso 2515 NAV eco Variable Electrophysiology (EP) CatheterSterilmed, 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.

↑