Cleared Traditional

AcQMap 3D Imaging and Mapping Catheter

K170819 · Acutus Medical, Inc. · Cardiovascular
Oct 2017
Decision
210d
Days
Class 2
Risk

About This 510(k) Submission

K170819 is an FDA 510(k) clearance for the AcQMap 3D Imaging and Mapping Catheter, a Catheter, Intracardiac Mapping, High-density Array (Class II — Special Controls, product code MTD), submitted by Acutus Medical, Inc. (Carlsbad, US). The FDA issued a Cleared decision on October 16, 2017, 210 days after receiving the submission on March 20, 2017. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1220.

Submission Details

510(k) Number K170819 FDA.gov
FDA Decision Cleared SESE
Date Received March 20, 2017
Decision Date October 16, 2017
Days to Decision 210 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

Similar Devices — MTD Catheter, Intracardiac Mapping, High-density Array

All 32
OptiMap Catheter - 50mm (OPTI-CATH2-50)
K253205 · Cortex, Inc. · Mar 2026
Sphere-9Dx Diagnostic Catheter (AFR-00009)
K233433 · Medtronic · Aug 2024
Advisor? HD Grid X Mapping Catheter, Sensor Enabled?
K241372 · Abbott Medical · Jul 2024
PENTARAY? NAV ECO High Density Mapping Catheter, DECANAV? Mapping Catheter, Webster? CS Catheter with Auto ID, Webster? CS Catheter with EZ Steer Technology, Webster? CS Catheter with EZ Steer Technology with Auto ID
K231312 · Biosense Webster, Inc. · Jul 2023
Ablacath? Mapping Catheter
K223666 · Ablacon, Inc. · Mar 2023
OPTRELL? Mapping Catheter with TRUEref? Technology
K230253 · Biosense Webster, Inc. · Mar 2023