Cleared Traditional

OPTRELL Mapping Catheter with TRUEref Technology

K211438 · Biosense Webster, Inc. · Cardiovascular
Mar 2022
Decision
312d
Days
Class 2
Risk

About This 510(k) Submission

K211438 is an FDA 510(k) clearance for the OPTRELL Mapping Catheter with TRUEref Technology, a Catheter, Intracardiac Mapping, High-density Array (Class II — Special Controls, product code MTD), submitted by Biosense Webster, Inc. (Irvine, US). The FDA issued a Cleared decision on March 18, 2022, 312 days after receiving the submission on May 10, 2021. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1220.

Submission Details

510(k) Number K211438 FDA.gov
FDA Decision Cleared SESE
Date Received May 10, 2021
Decision Date March 18, 2022
Days to Decision 312 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code MTD — Catheter, Intracardiac Mapping, High-density Array
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1220

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