Cleared Traditional

Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter

K233825 · Innovative Health · Cardiovascular
Jun 2024
Decision
189d
Days
Class 2
Risk

About This 510(k) Submission

K233825 is an FDA 510(k) clearance for the Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter, a Catheter, Recording, Electrode, Reprocessed (Class II — Special Controls, product code NLH), submitted by Innovative Health (Scottsdale, US). The FDA issued a Cleared decision on June 7, 2024, 189 days after receiving the submission on December 1, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1220.

Submission Details

510(k) Number K233825 FDA.gov
FDA Decision Cleared SESE
Date Received December 01, 2023
Decision Date June 07, 2024
Days to Decision 189 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code NLH — Catheter, Recording, Electrode, Reprocessed
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1220
Definition Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission. (70 Fr 56911, Available At Https://www.govinfo.gov/content/pkg/fr-2005-09-29/pdf/05-19510.pdf).

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