FIRMap Catheter
K-Number: K153093 · 2016-04-07
ApplicantAbbott Electrophysiology
Decision Date2016-04-07
Product CodeMTD
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
FIRMap Catheter is a medical device manufactured by Abbott Electrophysiology. It received FDA 510(k) clearance on 2016-04-07 under approval number K153093. The device is classified under product code MTD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the FIRMap Catheter?
FIRMap Catheter is a medical device that received FDA 510(k) clearance on 2016-04-07. It is manufactured by Abbott Electrophysiology. The 510(k) number is K153093.
When was FIRMap Catheter approved by the FDA?
FIRMap Catheter received FDA 510(k) clearance on 2016-04-07, under approval number K153093.
What company makes FIRMap Catheter?
FIRMap Catheter is manufactured by Abbott Electrophysiology.
What is the FDA product code for FIRMap Catheter?
The FDA product code for FIRMap Catheter is MTD.
Other Devices by Abbott Electrophysiology
Related Devices (Code: MTD)
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K172393Advisor HD Grid Mapping Catheter, Sensor EnabledSt. Jude Medical, Inc.
K201341AcQMap 3D Imaging and Mapping CatheterAcutus Medical, Inc.
K200212Reprocessed Advisor HD Grid Mapping Catheter, Sensor EnabledInnovative Health, LLC
K201750Pentaray Nav eco High-Density Mapping CatheterBiosense Webster, Inc.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.