13 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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Atricure Inc., Max1 Isolator Transpolar Pen. Model A000163. Used to ablate cardiac tissues during cardiac surgery using radiofrequency energy when connected to the AtriCure Ablation and Sensing Unit or for temporary cardiac pacing, sensing, recording, and stimulation during the evaluation of cardiac arrhythmias during surgery when connected to a temporary external cardiac pacemaker or recording device.
FDA Enforcement
Class II
·Terminated·Atricure Inc·March 13, 2013
Reusable Clip Applier Manufactured by AtriCure, Inc., 6217 Centre Park Drive, West Chester, OH 45069. The Reusable Clip Applier (Applier) is intended to be used to deploy the Gillinov-Cosgrove LAA Clip (Clip). The Gillinov-Cosgrove LAA Clip (Clip) is an implantable device used for occlusion of the left atrial appendage.
FDA Enforcement
Class II
·Terminated·Atricure Inc·March 26, 2014
Cryo Module Accessories Domestic CMA-OUS, Product Catalog Number A001053
FDA Enforcement
Class II
·Ongoing·AtriCure, Inc.·February 7, 2024
Packaged, Tank Hose Assembly CMA-US, Product Catalog Number A001056
FDA Enforcement
Class II
·Ongoing·AtriCure, Inc.·February 7, 2024
AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip Product is used for the occlusion of the heart's left atrial appendage, under direct visualization, in conjunction with other open cardiac surgical procedures.
FDA Enforcement
Class II
·Terminated·AtriCure, Inc.·November 16, 2016
COBRA Fusion 50 Ablation System, COBRA Fusion 150 Ablation System, and COBRA Fusion Magnetic Retriever System. Model Numbers: 700-001, 700-001S, 700-001MI, 700-002, and 700-003. Intended to ablate cardiac tissue during cardiac surgery using radiofrequency (RF) energy when connected directly to the Estech Electrosurgical unit (ESU).
FDA Enforcement
Class II
·Terminated·AtriCure, Inc.·November 30, 2016
AtriClip" LAA Exclusion System with preloaded Gillinov-Cosgrove" Clip - A single PRO2 device is packaged in a conventional thermoformed polyethylene terephthalate glycol (PETG) tray with a Tyvek¿ lid. A single-walled non-corrugated box completes the single unit package. Six (6) single unit PRO2 devices are packaged into one (1) corrugate shipper box.
FDA Enforcement
Class II
·Terminated·AtriCure, Inc.·February 15, 2017
Cryogenic probe for cardiac ablation surgery, packaged individually in Tyvek pouches Product Usage: Cryogenic probe for cardiac ablation surgery. The CryoICE cryoablation probe is a sterile, single use device intended to use in the cryosurgical treatment of cardiac arrhythmias. The probe freezes target tissues, creating an inflammatory response (cryo-necrosis) that blocks the electrical conduction pathway.
FDA Enforcement
Class II
·Terminated·Atricure Inc·January 7, 2015
COBRA FUSION 150 Ablation System (International Only), Catalog # (REF) 700-001MI
FDA Enforcement
Class II
·Terminated·AtriCure, Inc.·February 20, 2019
COBRA FUSION 150 Ablation System, Catalog # (REF) 700-001
FDA Enforcement
Class II
·Terminated·AtriCure, Inc.·February 20, 2019
COBRA FUSION 150 Ablation System, Catalog # (REF) 700-001S
FDA Enforcement
Class II
·Terminated·AtriCure, Inc.·February 20, 2019
COBRA FUSION 50, Ablation System, Catalog # (REF) 700-002
FDA Enforcement
Class II
·Terminated·AtriCure, Inc.·February 20, 2019
EPi-Sense Guided Coagulation System with Visitrax, MOdel No. CDK-1413 - Product Usage: The EPi-Sense Guided Coagulation System with VisiTrax, consists of a sterile, single-use, disposable coagulation electrode device (1cm, 2cm, and 3cm sizes provided) intended to be used to coagulate cardiac tissue. The flexible, cooled electrode device, with a suction stabilizer feature, transmits radiofrequency (RF) energy from an Electrosurgical Generator (non-sterile, re-useable) connected through an Instrument Cable (sterile). A temporary sensing electrode feature may be used with an off-the-shelf electrogram recording system with the use of an additional instrument cable (non-sterile). An accessory Cannula may be used to facilitate coagulation device access and visibility of the heart. The EPi-Sense Guided Coagulation System with VisiTrax technology is intended for the coagulation of cardiac tissue using Radiofrequency (RF) energy using thoracoscopic, endoscopic, and laparoscopic surgical techniques and may be used for temporary cardiac signal sensing and recording during surgery when connected to a temporary external recording device.
FDA Enforcement
Class II
·Terminated·AtriCure, Inc.·July 3, 2019