510(k) K223666

Device
Ablacath? Mapping Catheter
Applicant
Ablacon, Inc.
510(k) number
K223666
Product code
MTD
Decision
Substantially Equivalent (SESE)
Decision date
2023-03-17
Date received
2022-12-07
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
Frank Rodriguez
Address
4800 Wadsworth Blvd. Suite 310 Denver CO US 80033 80033

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MTD#

510(k), Device, Applicant table
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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