Cleared Traditional

Pentaray Nav eco High-Density Mapping Catheter

K201750 · Biosense Webster, Inc. · Cardiovascular
Aug 2020
Decision
41d
Days
Class 2
Risk

About This 510(k) Submission

K201750 is an FDA 510(k) clearance for the Pentaray Nav eco High-Density Mapping Catheter, a Catheter, Intracardiac Mapping, High-density Array (Class II — Special Controls, product code MTD), submitted by Biosense Webster, Inc. (Irvin, US). The FDA issued a Cleared decision on August 6, 2020, 41 days after receiving the submission on June 26, 2020. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1220.

Submission Details

510(k) Number K201750 FDA.gov
FDA Decision Cleared SESE
Date Received June 26, 2020
Decision Date August 06, 2020
Days to Decision 41 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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