FIRMap Catheter

FDA 510(k) K153093 · Abbott Electrophysiology

Substantially Equivalent

510(k) numberK153093

Submission

Device name
FIRMap Catheter
Applicant
Abbott Electrophysiology
Menlo Park, CA, US
Received
October 26, 2015
Decision date
April 7, 2016
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MTD – Catheter, Intracardiac Mapping, High-Density Array
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1220
Specialty
Cardiovascular

Other 510(k)s with product code MTD

510(k)DeviceApplicantDecision
K261012OptiMap Catheter - 60mm (OPTI-CATH2-60)MTD · Special Cortex, Inc.04/23/2026SE
K253205OptiMap Catheter - 50mm (OPTI-CATH2-50)MTD · Traditional Cortex, Inc.03/13/2026SE
K233433Sphere-9Dx Diagnostic Catheter (AFR-00009)MTD · Traditional Medtronic08/07/2024SE
K241372Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™MTD · Special Abbott Medical07/09/2024SE
K231312PENTARAY® NAV ECO High Density Mapping Catheter, DECANAV® Mapping Catheter, Webster® CS…MTD · Special Biosense Webster, Inc.07/10/2023SE
K223666Ablacath™ Mapping CatheterMTD · Traditional Ablacon, Inc.03/17/2023SE
K230253OPTRELL™ Mapping Catheter with TRUEref™ TechnologyMTD · Special Biosense Webster, Inc.03/02/2023SE
K210766AcQMap 3D Imaging and Mapping Catheter, Model 900009MTD · Traditional Acutus Medical, Inc.06/21/2022SE
K211438OPTRELL Mapping Catheter with TRUEref TechnologyMTD · Traditional Biosense Webster, Inc.03/18/2022SE
K201806Reprocessed PentaRay Nav eco High-Density Mapping CatheterMTD · Traditional Sterilmed Inc. (Johnson and Johnson)06/23/2021SE

More from Sterilmed Inc. (Johnson and Johnson)

510(k)DeviceDecision
K171583RhythmView WorkstationDQK · Traditional 09/01/2017SE
K163709FIRMap CatheterMTD · Traditional 02/28/2017SE
K161240Rhythm View Workstation (non-streaming)DQK · Traditional 08/10/2016SE

Questions and answers

When was FIRMap Catheter cleared by the FDA?

FIRMap Catheter (K153093) received a 510(k) decision of Substantially Equivalent on April 7, 2016, 164 days after the submission was received.

What is the product code of K153093?

The FDA product code is MTD – Catheter, Intracardiac Mapping, High-Density Array, a Class II (moderate risk) device regulated under 21 CFR 870.1220.