FDA.reportPublic FDA data

Vascular guide-catheter, single-use

Definition
A flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter, lead (e.g., pacing lead, balloon dilatation catheter), needle or guidewire through its lumen(s), within the vascular system. It may be rigid or flexible, non-steerable or steerable, single or multiple lumen(s), and the distal section can have a variety of preformed shapes (e.g., straight, hockey stick). It is not intended solely for infusion, is not intended to access superselective small vessels, and does not include a transseptal needle. It may include a disposable percutaneous introduction set or shaft visualization electrodes. This is a single-use device.
GUDID devices
162
Last updated
2026-02-10 23:51:55

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
38718122013985Primum Guiding CatheterPendraCare International B.V.6F Primum JR42026-02-02
38718122028897Primum Guiding CatheterPendraCare International B.V.6F Primum EBU3.52026-02-02
07540162100192Globe® IntroducerKardium Inc601-010012025-09-15
20841156111257GUIDELINERTELEFLEX INCORPORATEDIPN9301882025-07-14
20841156111264GUIDELINERTELEFLEX INCORPORATEDIPN9301892025-07-14
30841156111278GUIDELINERTELEFLEX INCORPORATEDIPN9301902025-07-14
30841156111285GUIDELINERTELEFLEX INCORPORATEDIPN9301912025-07-14
10843152101075IOPS ViewpointCENTERLINE BIOMEDICAL, INC.C012512024-10-01
10843152101105IOPS ViewpointCENTERLINE BIOMEDICAL, INC.C007522024-10-01
10843152101112IOPS ViewpointCENTERLINE BIOMEDICAL, INC.C012522024-10-01
20705032100554VISTA BRITE TIPCordis US Corp.588-842PM2024-09-09
20705032100578VISTA BRITE TIPCordis US Corp.670-052-00M2024-09-09
20705032100592VISTA BRITE TIPCordis US Corp.670-002-00M2024-09-09
20705032100615VISTA BRITE TIPCordis US Corp.778-054-00M2024-09-09
20705032100622VISTA BRITE TIPCordis US Corp.670-034-00M2024-09-09
20705032100646VISTA BRITE TIPCordis US Corp.670-083-00M2024-09-09
20705032100653VISTA BRITE TIPCordis US Corp.778-052-00M2024-09-09
20705032100660VISTA BRITE TIPCordis US Corp.778-082-00M2024-09-09
20705032100677VISTA BRITE TIPCordis US Corp.670-036-00M2024-09-09
20705032100691VISTA BRITE TIPCordis US Corp.556-082-0LM2024-09-09
20705032100707VISTA BRITE TIPCordis US Corp.670-110-00M2024-09-09
20705032100738VISTA BRITE TIPCordis US Corp.670-112-00M2024-09-09
20705032100745VISTA BRITE TIPCordis US Corp.670-190-00M2024-09-09
20705032100752VISTA BRITE TIPCordis US Corp.778-055-00M2024-09-09
20705032100769VISTA BRITE TIPCordis US Corp.670-055-00M2024-09-09
20705032100776VISTA BRITE TIPCordis US Corp.556-002-0LM2024-09-09
20705032100790VISTA BRITE TIPCordis US Corp.556-080-0LM2024-09-09
20705032100806VISTA BRITE TIPCordis US Corp.670-005-00M2024-09-09
20705032100813VISTA BRITE TIPCordis US Corp.556-054-0LM2024-09-09
20705032100820VISTA BRITE TIPCordis US Corp.778-037-00M2024-09-09
20705032100837VISTA BRITE TIPCordis US Corp.670-040-00M2024-09-09
20705032100844VISTA BRITE TIPCordis US Corp.778-080-00M2024-09-09
20705032100851VISTA BRITE TIPCordis US Corp.778-060-00M2024-09-09
20705032100868VISTA BRITE TIPCordis US Corp.670-270-90M2024-09-09
20705032100875VISTA BRITE TIPCordis US Corp.670-056-00M2024-09-09
20705032100882VISTA BRITE TIPCordis US Corp.670-270-00M2024-09-09
20705032100899VISTA BRITE TIPCordis US Corp.778-034-00M2024-09-09
20705032100905VISTA BRITE TIPCordis US Corp.670-072-00M2024-09-09
20705032100912VISTA BRITE TIPCordis US Corp.670-080-00M2024-09-09
20705032100929VISTA BRITE TIPCordis US Corp.670-008-00M2024-09-09
20705032100936VISTA BRITE TIPCordis US Corp.556-004-0LM2024-09-09
20705032100943VISTA BRITE TIPCordis US Corp.670-003-00M2024-09-09
20705032100950VISTA BRITE TIPCordis US Corp.778-270-00M2024-09-09
20705032100967VISTA BRITE TIPCordis US Corp.556-056-0LM2024-09-09
20705032100974VISTA BRITE TIPCordis US Corp.778-111-00M2024-09-09
20705032100981VISTA BRITE TIPCordis US Corp.588-882M2024-09-09
20705032100998VISTA BRITE TIPCordis US Corp.778-057-00M2024-09-09
20705032101001VISTA BRITE TIPCordis US Corp.670-060-00M2024-09-09
20841156109049GUIDELINERTELEFLEX INCORPORATEDIPN9225802024-07-15
20841156109018GUIDELINERTELEFLEX INCORPORATEDIPN9225772024-07-12
20841156109025GUIDELINERTELEFLEX INCORPORATEDIPN9225782024-07-12
20841156109032GUIDELINERTELEFLEX INCORPORATEDIPN9225792024-07-12
20763000770291TrailBlazer™MEDTRONIC, INC.ASC-014-0902024-07-08
20763000770307TrailBlazer™MEDTRONIC, INC.ASC-014-1352024-07-08
20763000770314TrailBlazer™MEDTRONIC, INC.ASC-014-1502024-07-08
20763000770321TrailBlazer™MEDTRONIC, INC.ASC-018-0902024-07-08
20763000770338TrailBlazer™MEDTRONIC, INC.ASC-018-1352024-07-08
20763000770345TrailBlazer™MEDTRONIC, INC.ASC-018-1502024-07-08
20763000770352TrailBlazer™MEDTRONIC, INC.ASC-035-0652024-07-08
20763000770369TrailBlazer™MEDTRONIC, INC.ASC-035-0902024-07-08
20763000770376TrailBlazer™MEDTRONIC, INC.ASC-035-1352024-07-08
20763000770383TrailBlazer™MEDTRONIC, INC.ASC-035-1502024-07-08
40841156109111GUIDELINERTELEFLEX INCORPORATEDIPN9292862024-04-16
20705032019054VISTA BRITE TIPCORDIS CORPORATION598941P2024-02-23
20705032019177VISTA BRITE TIPCORDIS CORPORATION598949P2024-02-23
20705032020135VISTA BRITE TIPCORDIS CORPORATION670048002024-02-23
20705032042953VISTA BRITE TIPCORDIS CORPORATIONSM74972024-02-23
20705032043066VISTA BRITE TIPCORDIS CORPORATIONSM75402024-02-23
20705032043141VISTA BRITE TIPCORDIS CORPORATIONSM75482024-02-23
20705032043158VISTA BRITE TIPCORDIS CORPORATIONSM75492024-02-23
20705032043431VISTA BRITE TIPCORDIS CORPORATIONSM75962024-02-23
20705032043776VISTA BRITE TIPCORDIS CORPORATIONSM76522024-02-23
20705032047057VISTA BRITE TIPCORDIS CORPORATIONSRA0002IG2024-02-23
20705032047132VISTA BRITE TIPCORDIS CORPORATIONSRA0016IG2024-02-23
00191506019570Rubicon™ ControlBOSTON SCIENTIFIC CORPORATIONH749394321409A02024-02-16
00191506019594Rubicon™ ControlBOSTON SCIENTIFIC CORPORATIONH749394321413A02024-02-16
00191506019617Rubicon™ ControlBOSTON SCIENTIFIC CORPORATIONH749394321415A02024-02-16
00191506019631Rubicon™ ControlBOSTON SCIENTIFIC CORPORATIONH749394321809A02024-02-16
00191506019655Rubicon™ ControlBOSTON SCIENTIFIC CORPORATIONH749394321813A02024-02-16
00191506019679Rubicon™ ControlBOSTON SCIENTIFIC CORPORATIONH749394321815A02024-02-16