FDA.reportPublic FDA data

Bronchial balloon catheter

Definition
A sterile flexible tube designed with a balloon at or near the distal tip that may be introduced directly (usually under fluoroscopic guidance) or through a bronchoscope so that its distal tip reaches the bronchi, permitting the inflation of the balloon after introduction. The device is typically used to treat benign stenosis and strictures of the airway and/or to control pulmonary bleeding (i.e., hemoptysis). This is a single-use device.
GUDID devices
178
Last updated
2026-10-04 01:13:23

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
10705031063297INSPIRA AIRACCLARENT, INC.BC1040A2016-09-01
10705031063310INSPIRA AIRACCLARENT, INC.BC1440A2016-09-01
10705031131996INSPIRA AIRACCLARENT, INC.BC0524A2016-09-01
10705031132061INSPIRA AIRACCLARENT, INC.BC0724A2016-09-01
10705031147737INSPIRA AIRACCLARENT, INC.BC1240A2016-09-01
10705031147744INSPIRA AIRACCLARENT, INC.BC1640A2016-09-01
10705031206052INSPIRA AIRACCLARENT, INC.BC8524A2016-09-01
20705031063089INSPIRA AIRACCLARENT, INC.BC0524AZ2016-09-01
20705031063126INSPIRA AIRACCLARENT, INC.BC0724AZ2016-09-01
20705031063157INSPIRA AIRACCLARENT, INC.BC1040AZ2016-09-01
20705031063171INSPIRA AIRACCLARENT, INC.BC1440AZ2016-09-01
20705031147703INSPIRA AIRACCLARENT, INC.BC1240AZ2018-03-31
20705031242682INSPIRA AIRACCLARENT, INC.BC8524AZ2018-03-31
00811907030928Chartis CatheterPULMONX CORPORATIONG32018-10-03
00884450197950Elation™Merit Medical Systems, Inc.008844501979502017-01-20
00884450197967Elation™Merit Medical Systems, Inc.008844501979672017-01-20
00884450197974Elation™Merit Medical Systems, Inc.008844501979742017-01-20
00884450197981Elation™Merit Medical Systems, Inc.008844501979812017-01-24
00884450197998Elation™Merit Medical Systems, Inc.008844501979982017-01-19
00884450198001Elation™Merit Medical Systems, Inc.008844501980012017-01-19
00884450198018Elation™Merit Medical Systems, Inc.008844501980182017-01-24
00884450198025Elation™Merit Medical Systems, Inc.008844501980252017-02-09
00884450198032Elation™Merit Medical Systems, Inc.008844501980322017-01-27
00884450198049Elation™Merit Medical Systems, Inc.008844501980492017-01-25
00884450198056Elation™Merit Medical Systems, Inc.008844501980562017-01-25
00884450398913Elation™Merit Medical Systems, Inc.008844503989132018-12-06
00884450398920Elation™Merit Medical Systems, Inc.008844503989202018-11-06
00884450398937Elation™Merit Medical Systems, Inc.008844503989372019-01-16
00884450398944Elation™Merit Medical Systems, Inc.008844503989442018-12-10
00884450398951Elation™Merit Medical Systems, Inc.008844503989512018-11-27
00884450398968Elation™Merit Medical Systems, Inc.008844503989682018-11-26
00884450398982Elation™Merit Medical Systems, Inc.008844503989822018-10-15
00884450399002Elation™Merit Medical Systems, Inc.008844503990022018-12-06
00884450399019Elation™Merit Medical Systems, Inc.008844503990192018-11-12
00884450593837Elation™Merit Medical Systems, Inc.008844505938372022-06-23
04026704042463RUSCHTELEFLEX INCORPORATEDIPN0442172015-10-16
04026704042470RUSCHTELEFLEX INCORPORATEDIPN0442182015-10-16
04026704095490RUSCHTELEFLEX INCORPORATEDIPN0442192015-10-16
04544050123921UNIBLOCKERFUJI SYSTEMS CORPORATION9.0FR2023-09-05
06009698453161Trachealator Non-occlusive Airway Dilation BalloonDISA MEDINOTEC (PTY) LTDTRD1-145402026-05-20
06009698453178Trachealator Non-occlusive Airway Dilation BalloonDISA MEDINOTEC (PTY) LTDTRD1-160402026-05-20
06009698453185Trachealator Non-occlusive Airway Dilation BalloonDISA MEDINOTEC (PTY) LTDTRD1-180402026-05-20
06009698453192Trachealator Non-occlusive Airway Dilation BalloonDISA MEDINOTEC (PTY) LTDTRD1-060302026-05-19
06009698453208Trachealator Non-occlusive Airway Dilation BalloonDISA MEDINOTEC (PTY) LTDTRD1-070302026-05-20
06009698453215Trachealator Non-occlusive Airway Dilation BalloonDISA MEDINOTEC (PTY) LTDTRD1-080302026-05-20
06009698453222Trachealator Non-occlusive Airway Dilation BalloonDISA MEDINOTEC (PTY) LTDTRD1-090302026-05-20
06009698453239Trachealator Non-occlusive Airway Dilation BalloonDISA MEDINOTEC (PTY) LTDTRD1-100302026-05-20
06009698453246Trachealator Non-occlusive Airway Dilation BalloonDISA MEDINOTEC (PTY) LTDTRD1-120402026-05-20
06970831723369InsightersShenzhen Insighters Medical Technology Co., Ltd.5Fr2026-04-10
06970831723376InsightersShenzhen Insighters Medical Technology Co., Ltd.7Fr2026-04-10
06970831723383InsightersShenzhen Insighters Medical Technology Co., Ltd.9Fr2026-04-10
07290013745545VivaSight PackE.T. VIEW LTDTVEB701002016-09-24
07290013745774VivaSight AS Pack Set includeE.T. VIEW LTDTVEB70100AS2018-02-21
07290013745781VivaSight AS Pack Set includeE.T. VIEW LTDTVEB75105AS2018-02-21
07290013745798VivaSight AS Pack Set includeE.T. VIEW LTDTVEB80110AS2018-02-21
07290013745804VivaSight-EBE.T. VIEW LTDEBB09700AS2018-02-21
08714729456186CRE PulmonaryBOSTON SCIENTIFIC CORPORATIONM005503002016-09-24
08714729456193CRE PulmonaryBOSTON SCIENTIFIC CORPORATIONM005503102016-09-24
08714729456209CRE PulmonaryBOSTON SCIENTIFIC CORPORATIONM005503202016-09-24
08714729456216CRE PulmonaryBOSTON SCIENTIFIC CORPORATIONM005503302016-09-24
08714729456223CRE PulmonaryBOSTON SCIENTIFIC CORPORATIONM005503402016-09-24
08714729456230CRE PulmonaryBOSTON SCIENTIFIC CORPORATIONM005503502016-09-24
06934184007088MultiStage®Dongguan TT Medical, Inc.MSO-0630-092025-02-10
06934184007095MultiStage®Dongguan TT Medical, Inc.MSO-0830-092025-02-10
06934184007101MultiStage®Dongguan TT Medical, Inc.MSO-1030-092025-02-10
06934184007118MultiStage®Dongguan TT Medical, Inc.MSO-1530-092025-02-10
06934184007125MultiStage®Dongguan TT Medical, Inc.MSO-1230-092025-02-10
06934184007132MultiStage®Dongguan TT Medical, Inc.MSO-1830-092025-02-10
06934184007149MultiStage®Dongguan TT Medical, Inc.MSO-0655-092025-02-10
06934184007156MultiStage®Dongguan TT Medical, Inc.MSO-0855-092025-02-10
06934184007163MultiStage®Dongguan TT Medical, Inc.MSO-1055-092025-02-10
06934184007170MultiStage®Dongguan TT Medical, Inc.MSO-1255-092025-02-10
06934184007187MultiStage®Dongguan TT Medical, Inc.MSO-1555-092025-02-10
06934184007194MultiStage®Dongguan TT Medical, Inc.MSO-1855-092025-02-10
06934184007200MultiStage®Dongguan TT Medical, Inc.MSW-0630-092025-02-10
06934184007217MultiStage®Dongguan TT Medical, Inc.MSW-0830-092025-02-10
06934184007224MultiStage®Dongguan TT Medical, Inc.MSW-1030-092025-02-10
06934184007231MultiStage®Dongguan TT Medical, Inc.MSW-1230-092025-02-10
06934184007248MultiStage®Dongguan TT Medical, Inc.MSW-1530-092025-02-10
06934184007255MultiStage®Dongguan TT Medical, Inc.MSW-1830-092025-02-10