FDA.reportPublic FDA data

Cardiac cryosurgical system catheter

Definition
A sterile, flexible device intended to be used as part of a cardiac tissue cryosurgical system to cryogenically ablate areas of the endocardium of a beating heart in the treatment of cardiac arrhythmias. It is intended to be introduced into the heart via venous access (e.g., femoral vein) and deliver pressurized liquid refrigerant (e.g., nitrous oxide) to its distal cooling segment to achieve extremely low temperatures through gas expansion; it typically includes sensors (e.g., temperature monitoring). This is a single-use device.
GUDID devices
89
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00763000542092Freezor™ XtraMEDTRONIC, INC.217F12022-04-11
00763000542108Freezor™ XtraMEDTRONIC, INC.217F32022-04-11
00763000542115Freezor™ XtraMEDTRONIC, INC.217F52022-04-11
00191506016463POLARx™ FITBOSTON SCIENTIFIC CORPORATIONM004CRBS21602023-08-21
08714729992615POLARx™BOSTON SCIENTIFIC CORPORATIONM004CRBS20502023-08-21
08714729992622POLARx™ FITBOSTON SCIENTIFIC CORPORATIONM004CRBS20602023-08-21
08714729992677POLARx™BOSTON SCIENTIFIC CORPORATIONM004CRBS21502023-08-21
00763000431518Arctic Front Advance™MEDTRONIC, INC.2AF2342023-04-07
00763000431532Arctic Front Advance™MEDTRONIC, INC.2AF2842023-04-07
00763000707774Arctic Front Advance Pro™MEDTRONIC, INC.AFAPRO232023-04-06
00763000707781Arctic Front Advance Pro™MEDTRONIC, INC.AFAPRO282023-04-06
00763000655136Freezor™ MAXMEDTRONIC, INC.209F32022-06-10
00763000655143Freezor™ MAXMEDTRONIC, INC.209F52022-06-10
00763000645328Freezor™MEDTRONIC, INC.207F12022-04-30
00763000645335Freezor™MEDTRONIC, INC.207F32022-04-30
00763000645342Freezor™MEDTRONIC, INC.207F52022-04-30
00763000431488Arctic Front Advance™MEDTRONIC, INC.2AF2342021-11-13
00763000431501Arctic Front Advance™MEDTRONIC, INC.2AF2842021-11-13
00763000431457Arctic Front Advance Pro™MEDTRONIC, INC.AFAPRO232021-11-05
00763000431464Arctic Front Advance Pro™MEDTRONIC, INC.AFAPRO282021-11-05
00763000341497Arctic Front Advance Pro™MEDTRONIC, INC.AFAPRO232021-10-23
00763000341503Arctic Front Advance Pro™MEDTRONIC, INC.AFAPRO282021-10-23
00763000245481Freezor® MAXMEDTRONIC, INC.239F52020-12-25
00763000245474Freezor® MAXMEDTRONIC, INC.239F32020-12-24
00763000341473Arctic Front Advance™MEDTRONIC, INC.2AF2342020-04-25
00763000341480Arctic Front Advance™MEDTRONIC, INC.2AF2842020-04-25
00763000245412Arctic Front Advance Pro™MEDTRONIC, INC.AFAPRO232019-10-24
00763000245436Arctic Front Advance Pro™MEDTRONIC, INC.AFAPRO282019-10-24
00643169878327Arctic Front Advance™MEDTRONIC, INC.2AF2342019-08-26
00643169878365Arctic Front Advance™MEDTRONIC, INC.2AF2842019-08-26
00643169976368Arctic Front Advance™MEDTRONIC, INC.2AF2342019-03-23
00643169976382Arctic Front Advance™MEDTRONIC, INC.2AF2842019-03-23
00763000088637Arctic Front Advance Pro™MEDTRONIC, INC.AFAPRO282019-03-23
00763000197766Arctic Front Advance Pro™MEDTRONIC, INC.AFAPRO232019-03-23
00643169345591Arctic Front Advance™MEDTRONIC, INC.2AF2342014-09-23
00643169345614Arctic Front Advance™MEDTRONIC, INC.2AF2842014-09-23
00643169450325Freezor® XtraMEDTRONIC, INC.227F12014-12-01
00643169450332Freezor® XtraMEDTRONIC, INC.227F32014-12-01
00643169450349Freezor® XtraMEDTRONIC, INC.227F52014-12-01
00643169450356Freezor® MAXMEDTRONIC, INC.229F32014-12-01
00643169450363Freezor® MAXMEDTRONIC, INC.229F52014-12-01
00643169450370Freezor® MAXMEDTRONIC, INC.239F32014-12-01
00643169450387Freezor® MAXMEDTRONIC, INC.239F52014-12-01
00643169450394Freezor®MEDTRONIC, INC.307F12014-12-01
00643169450400Freezor®MEDTRONIC, INC.307F32014-12-01
00643169450417Freezor®MEDTRONIC, INC.307F52014-12-01
00643169504745Freezor®MEDTRONIC, INC.307F52015-09-18
00643169504752Freezor®MEDTRONIC, INC.307F32015-09-18
00643169504769Freezor®MEDTRONIC, INC.307F12015-09-18
00643169504783Arctic Front Advance™MEDTRONIC, INC.2AF2842015-01-30
00643169504837Arctic Front®MEDTRONIC, INC.2AF2342015-07-21
00643169504899Freezor® MAXMEDTRONIC, INC.239F52015-09-18
00643169504905Freezor® MAXMEDTRONIC, INC.239F32015-09-18
00643169504912Freezor® MAXMEDTRONIC, INC.229F52015-09-18
00643169504929Freezor® MAXMEDTRONIC, INC.229F32015-09-18
00643169504936Freezor® XtraMEDTRONIC, INC.227F52015-09-18
00643169504943Freezor® XtraMEDTRONIC, INC.227F32015-09-18
00643169504950Freezor® XtraMEDTRONIC, INC.227F12015-09-18
00643169577732Arctic Front Advance® STMEDTRONIC, INC.2AFAST232015-05-28
00643169577749Arctic Front Advance® STMEDTRONIC, INC.2AFAST282015-05-28
00643169672468Freezor® XtraMEDTRONIC, INC.227F12017-02-16
00643169672475Freezor® XtraMEDTRONIC, INC.227F32017-02-16
00643169672482Freezor® XtraMEDTRONIC, INC.227F52017-02-16
00643169753686Arctic Front Advance™MEDTRONIC, INC.2AF2342016-09-09
00643169753693Arctic Front Advance™MEDTRONIC, INC.2AF2842016-09-09
00643169889880Arctic Front Advance Pro™MEDTRONIC, INC.AFAPRO232019-01-21
00643169889903Arctic Front Advance Pro™MEDTRONIC, INC.AFAPRO282019-01-21
00643169939271Arctic Front Advance™MEDTRONIC, INC.2AF2342018-06-25
00643169939318Arctic Front Advance™MEDTRONIC, INC.2AF2842018-06-25
00643169007574Arctic Front®MEDTRONIC, INC.2AF2322014-09-23
00643169007581Arctic Front®MEDTRONIC, INC.2AF2822014-09-23
00643169023420Freezor®MEDTRONIC, INC.307F52014-09-23
00643169023437Freezor®MEDTRONIC, INC.307F32014-09-23
00643169023444Freezor®MEDTRONIC, INC.307F12014-09-23
00643169023475Freezor® MAXMEDTRONIC, INC.239F52014-09-23
00643169023482Freezor® MAXMEDTRONIC, INC.239F32014-09-23
00643169023499Freezor® MAXMEDTRONIC, INC.229F52014-09-23
00643169023505Freezor® MAXMEDTRONIC, INC.229F32014-09-23
00643169023512Freezor® XtraMEDTRONIC, INC.227F52014-09-23
00643169023529Freezor® XtraMEDTRONIC, INC.227F32014-09-23