Cleared Traditional

Reprocessed DECANAV? Electrophysiology Catheter; Reprocessed WEBSTER? Duo-Decapolar Electrophysiology Catheter

K240826 · Sterilmed, Inc. · Cardiovascular
Oct 2024
Decision
199d
Days
Class 2
Risk

About This 510(k) Submission

K240826 is an FDA 510(k) clearance for the Reprocessed DECANAV? Electrophysiology Catheter; Reprocessed WEBSTER? Duo-Decapolar Electrophysiology Catheter, a Catheter, Recording, Electrode, Reprocessed (Class II — Special Controls, product code NLH), submitted by Sterilmed, Inc. (Plymouth, US). The FDA issued a Cleared decision on October 11, 2024, 199 days after receiving the submission on March 26, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1220.

Submission Details

510(k) Number K240826 FDA.gov
FDA Decision Cleared SESE
Date Received March 26, 2024
Decision Date October 11, 2024
Days to Decision 199 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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