Cleared Special

OPTRELL? Mapping Catheter with TRUEref? Technology

K230253 · Biosense Webster, Inc. · Cardiovascular
Mar 2023
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K230253 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 2, 2023, 30 days after receiving the submission on January 31, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1220.

Submission Details

510(k) Number K230253 FDA.gov
FDA Decision Cleared SESE
Date Received January 31, 2023
Decision Date March 02, 2023
Days to Decision 30 days
Submission Type Special
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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