CARTO ENT System
K-Number: K161701 · 2016-10-24
ApplicantBiosense Webster
Decision Date2016-10-24
Product CodePGW
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
CARTO ENT System is a medical device manufactured by Biosense Webster. It received FDA 510(k) clearance on 2016-10-24 under approval number K161701. The device is classified under product code PGW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the CARTO ENT System?
CARTO ENT System is a medical device that received FDA 510(k) clearance on 2016-10-24. It is manufactured by Biosense Webster. The 510(k) number is K161701.
When was CARTO ENT System approved by the FDA?
CARTO ENT System received FDA 510(k) clearance on 2016-10-24, under approval number K161701.
What company makes CARTO ENT System?
CARTO ENT System is manufactured by Biosense Webster.
What is the FDA product code for CARTO ENT System?
The FDA product code for CARTO ENT System is PGW.
Related Clinical Trials
NCT07572253
A Study of Using CARTO SOUND™ FAM to Guide Pulsed Field Ablation for Atrial Fibrillation
NOT_YET_RECRUITING
NCT04750798
An Observational Post-marketing Study Using Commercially Approved Biosense Webster (BWI) Medical Devices for the Treatment of Participants With Cardiac Arrhythmias
RECRUITING
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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.