FDA.reportPublic FDA data

Atrial cardioversion system catheter

Definition
A sterile, thin, flexible tube that interfaces proximally with an electrocardiogram (ECG) monitor/recorder and defibrillator, and distally with the myocardium, for electrical cardioversion (CV) to treat atrial tachyarrhythmias [e.g., atrial fibrillation (AF)]. It typically has multiple lumens with specific functions (e.g., for various electrode arrays, guidewire, air) and may be balloon-tipped to facilitate transvenous placement; it may have sensing, pacing, and pressure measurement capabilities. This is a single-use device.
GUDID devices
48
Last updated
2020-04-28 00:36:08

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00836559006633HELIOSOscor Inc.H05110S2015-10-16
00836559006640HELIOSOscor Inc.H05110U2015-10-16
00836559007258HELIOSOscor Inc.HK05110S2015-10-16
00836559007265HELIOSOscor Inc.HK05110U2015-10-16
00836559009023TBOscor Inc.TBK04110SSG2015-10-16
00836559009030TBOscor Inc.TBK04110USG2015-10-16
00836559009047TBOscor Inc.TBK05110SSG2015-10-16
00836559009054TBOscor Inc.TBK05110USG2015-10-16
00836559009061TBOscor Inc.TBK06110SSG2015-10-16
00836559009078TBOscor Inc.TBK06110USG2015-10-16
00836559009696TBOscor Inc.0200012015-10-16
00836559009702TBOscor Inc.0200022015-10-16
00836559009719TBOscor Inc.0200032015-10-16
00836559009726TBOscor Inc.0200042015-10-16
00836559009733TBOscor Inc.0200052015-10-16
00836559009740TBOscor Inc.0200062015-10-16
00836559009757TBOscor Inc.0200072015-10-16
00836559009764TBOscor Inc.0200082015-10-16
00836559009771TBOscor Inc.0200092015-10-16
00836559009788TBOscor Inc.0200102015-10-16
00836559009795TBOscor Inc.0200112015-10-16
00836559009801TBOscor Inc.0200122015-10-16
00836559009818TBOscor Inc.0200132015-10-16
00836559009825TBOscor Inc.0200142015-10-16
00836559009832TBOscor Inc.0200152015-10-16
00836559009849TBOscor Inc.0200162015-10-16
00836559009856TBOscor Inc.0200172015-10-16
00836559009863TBOscor Inc.0200182015-10-16
00836559009870TBOscor Inc.0200192015-10-16
00836559009887TBOscor Inc.0200202015-10-16
00836559009894TBOscor Inc.0200212015-10-16
00836559009900TBOscor Inc.0200222015-10-16
00836559009917TBOscor Inc.0200232015-10-16
00836559009924TBOscor Inc.0200242015-10-16
00885672001520HELIOSOscor Inc.H05RH110U2015-10-16
00885672001537HELIOSOscor Inc.H05RH110S2015-10-16
00885672001865HELIOSOscor Inc.HRHCK05110U2015-10-16
00885672001872HELIOSOscor Inc.HRHCK05110S2015-10-16
00885672004347TBOscor Inc.TBVK06110SSG2017-11-27
00885672004354TBOscor Inc.TBVK06110USG2017-11-27
00885672004361TBOscor Inc.TBRHK04110SSG2017-11-27
00885672004378TBOscor Inc.TBRHK04110USG2017-11-27
00885672004385TBOscor Inc.TBRHK05110SSG2017-11-27
00885672004392TBOscor Inc.TBRHK05110USG2017-11-27
00885672007027TBOscor Inc.TBVK04110USG2017-11-27
00885672007034TBOscor Inc.TBJK04110USG2017-11-27
00885672103675TBOscor Inc.TBRHK06110SSG2017-11-27
00885672103682TBOscor Inc.TBRHK06110USG2017-11-27