FDA.reportPublic FDA data

510(k) K210766

Device
AcQMap 3D Imaging and Mapping Catheter, Model 900009
Applicant
Acutus Medical, Inc.
510(k) number
K210766
Product code
MTD
Decision
Substantially Equivalent (SESE)
Decision date
2022-06-21
Date received
2021-03-15
Regulation
870.1220
Classification name
Catheter, Intracardiac Mapping, High-Density Array
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Karla Schaffner
Address
2210 Faraday Ave., Suite 100 Carlsbad CA US 92008 92008

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MTD#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K261012OptiMap Catheter - 60mm (OPTI-CATH2-60)Cortex, Inc.2026-04-23
K253205OptiMap Catheter - 50mm (OPTI-CATH2-50)Cortex, Inc.2026-03-13
K233433Sphere-9Dx Diagnostic Catheter (AFR-00009)Medtronic2024-08-07
K241372Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™ABBOTT MEDICAL2024-07-09
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K223666Ablacath™ Mapping CatheterAblacon, Inc.2023-03-17
K230253OPTRELL™ Mapping Catheter with TRUEref™ TechnologyBiosense Webster, Inc.2023-03-02
K211438OPTRELL Mapping Catheter with TRUEref TechnologyBiosense Webster, Inc.2022-03-18
K201806Reprocessed PentaRay Nav eco High-Density Mapping CatheterSterilmed Inc. (Johnson and Johnson)2021-06-23
K201341AcQMap 3D Imaging and Mapping CatheterAcutus Medical, Inc.2020-09-15
K200212Reprocessed Advisor HD Grid Mapping Catheter, Sensor EnabledInnovative Health, LLC2020-09-03
K201750Pentaray Nav eco High-Density Mapping CatheterBiosense Webster, Inc.2020-08-06
K193237Carto Octaray Mapping Catheter with Trueref TechnologyBiosense Webster, Inc.2020-07-31
K172393Advisor HD Grid Mapping Catheter, Sensor EnabledSt. Jude Medical, Inc.2018-04-23
K170819AcQMap 3D Imaging and Mapping CatheterAcutus Medical, Inc.2017-10-16