FDA.reportPublic FDA data

Oesophageal balloon catheter

Definition
A long, flexible device with an inflatable balloon(s) at its distal end designed to access the length of the oesophagus of adult and adolescent patients to dilate strictures through balloon inflation. It is typically constructed as a catheter of various designs and is usually used endoscopically to enable visualization during the procedure. It is typically used to dilate strictures due to oesophageal surgery, primary gastric reflux, radiation therapy, and dilatation of the cardia in patients with achalasia (failure to relax the lower oesophageal sphincter). This is a single-use device.
GUDID devices
86
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00884450197776Elation™Merit Medical Systems, Inc.008844501977762016-09-24
00884450197783Elation™Merit Medical Systems, Inc.008844501977832016-09-24
00884450197806Elation™Merit Medical Systems, Inc.008844501978062016-09-23
00884450197813Elation™Merit Medical Systems, Inc.008844501978132016-09-24
00884450197820Elation™Merit Medical Systems, Inc.008844501978202016-09-24
00884450258002Elation™Merit Medical Systems, Inc.008844502580022016-03-04
00884450258019Elation™Merit Medical Systems, Inc.008844502580192016-03-04
00884450258033Elation™Merit Medical Systems, Inc.008844502580332016-03-03
00884450258064Elation™Merit Medical Systems, Inc.008844502580642016-03-04
00884450258071Elation™Merit Medical Systems, Inc.008844502580712016-03-03
00884450258088Elation™Merit Medical Systems, Inc.008844502580882016-03-04
00884450258095Elation™Merit Medical Systems, Inc.008844502580952016-03-03
00884450258101Elation™Merit Medical Systems, Inc.008844502581012016-03-04
00884450258118Elation™Merit Medical Systems, Inc.008844502581182016-03-03
00884450258125Elation™Merit Medical Systems, Inc.008844502581252016-03-04
00884450258132Elation™Merit Medical Systems, Inc.008844502581322016-03-04
00884450258149Elation™Merit Medical Systems, Inc.008844502581492016-03-04
08714729163039XXL™ EsophagealBOSTON SCIENTIFIC CORPORATIONM0011455002016-09-24
08714729163053XXL™ EsophagealBOSTON SCIENTIFIC CORPORATIONM0011455102016-09-24
08714729163060XXL™ EsophagealBOSTON SCIENTIFIC CORPORATIONM0011455202016-09-24
08714729163084XXL™ EsophagealBOSTON SCIENTIFIC CORPORATIONM0011455302016-09-24
08714729163114XXL™ EsophagealBOSTON SCIENTIFIC CORPORATIONM0011455402016-09-24
08714729163121XXL™ EsophagealBOSTON SCIENTIFIC CORPORATIONM0011455502016-09-24
08714729163145XXL™ EsophagealBOSTON SCIENTIFIC CORPORATIONM0011455602016-09-24
08714729163169XXL™ EsophagealBOSTON SCIENTIFIC CORPORATIONM0011455702016-09-24
08714729163176XXL™ EsophagealBOSTON SCIENTIFIC CORPORATIONM0011455802016-09-24
08714729163190XXL™ EsophagealBOSTON SCIENTIFIC CORPORATIONM0011455902016-09-24
16932503523032Reliant(TM) Multistage Dilatation Balloon CatheterMicro-Tech (Nanjing) Co., Ltd.MBD-AM-BB-22016-02-29
26932503523015NAMicro-Tech (Nanjing) Co., Ltd.MBD-AL-BA-22016-02-29
26932503523022NAMicro-Tech (Nanjing) Co., Ltd.MBD-AM-BA-22016-02-29
26932503523046NAMicro-Tech (Nanjing) Co., Ltd.MBD-AS-BB-22016-03-01
26932503523053NAMicro-Tech (Nanjing) Co., Ltd.MBD-BL-BA-22016-03-01
26932503523060NAMicro-Tech (Nanjing) Co., Ltd.MBD-BM-BA-22016-03-01
26932503523084NAMicro-Tech (Nanjing) Co., Ltd.MBD-BS-BB-22016-03-08
26932503523107NAMicro-Tech (Nanjing) Co., Ltd.MBD-CM-BA-22016-03-08
26932503523121NAMicro-Tech (Nanjing) Co., Ltd.MBD-CS-BB-22016-03-08
26932503523145NAMicro-Tech (Nanjing) Co., Ltd.MBD-DM-BA-22016-03-08
26932503523169NAMicro-Tech (Nanjing) Co., Ltd.MBD-DS-BB-22016-03-08
26932503523183NAMicro-Tech (Nanjing) Co., Ltd.MBD-EM-BA-22016-03-08
26932503523206NAMicro-Tech (Nanjing) Co., Ltd.MBD-FL-BA-22016-03-08
26932503523220NAMicro-Tech (Nanjing) Co., Ltd.MBD-FM-BB-22016-03-08
30888937003247CooperSurgical, Inc.Coopersurgical, Inc.47-90052016-09-15
06932503523011Reliant(TM) Multistage Dilatation Balloon CatheterMicro-Tech (Nanjing) Co., Ltd.MBD-AL-BA-22016-02-29
06932503523028Reliant(TM) Multistage Dilatation Balloon CatheterMicro-Tech (Nanjing) Co., Ltd.MBD-AM-BA-22016-02-29
06932503523035Reliant(TM) Multistage Dilatation Balloon CatheterMicro-Tech (Nanjing) Co., Ltd.MBD-AM-BB-22016-02-29
06932503523042Reliant(TM) Multistage Dilatation Balloon CatheterMicro-Tech (Nanjing) Co., Ltd.MBD-AS-BB-22016-03-01
06932503523059Reliant(TM) Multistage Dilatation Balloon CatheterMicro-Tech (Nanjing) Co., Ltd.MBD-BL-BA-22016-03-01
06932503523066Reliant(TM) Multistage Dilatation Balloon CatheterMicro-Tech (Nanjing) Co., Ltd.MBD-BM-BA-22016-03-01
06932503523073Reliant(TM) Multistage Dilatation Balloon CatheterMicro-Tech (Nanjing) Co., Ltd.MBD-BM-BB-22016-03-08
06932503523097Reliant(TM) Multistage Dilatation Balloon CatheterMicro-Tech (Nanjing) Co., Ltd.MBD-CL-BA-22016-03-08
06932503523110Reliant(TM) Multistage Dilatation Balloon CatheterMicro-Tech (Nanjing) Co., Ltd.MBD-CM-BB-22016-03-08
06932503523134Reliant(TM) Multistage Dilatation Balloon CatheterMicro-Tech (Nanjing) Co., Ltd.MBD-DL-BA-22016-03-08
06932503523158Reliant(TM) Multistage Dilatation Balloon CatheterMicro-Tech (Nanjing) Co., Ltd.MBD-DM-BB-22016-03-08
06932503523172Reliant(TM) Multistage Dilatation Balloon CatheterMicro-Tech (Nanjing) Co., Ltd.MBD-EL-BA-22016-03-08
06932503523196Reliant(TM) Multistage Dilatation Balloon CatheterMicro-Tech (Nanjing) Co., Ltd.MBD-EM-BB-22016-03-08
06932503523219Reliant(TM) Multistage Dilatation Balloon CatheterMicro-Tech (Nanjing) Co., Ltd.MBD-FM-BA-22016-03-08
10884450197766Elation™Merit Medical Systems, Inc.008844501977692016-09-24
10884450197773Elation™Merit Medical Systems, Inc.008844501977762016-09-24
10884450197780Elation™Merit Medical Systems, Inc.008844501977832016-09-24
10884450197803Elation™Merit Medical Systems, Inc.008844501978062016-09-23
10884450197810Elation™Merit Medical Systems, Inc.008844501978132016-09-24
10884450197827Elation™Merit Medical Systems, Inc.008844501978202016-09-24
10884450258016Elation™Merit Medical Systems, Inc.008844502580192016-03-04
10884450258078Elation™Merit Medical Systems, Inc.008844502580712016-03-03
10884450258092Elation™Merit Medical Systems, Inc.008844502580952016-03-03
10884450258108Elation™Merit Medical Systems, Inc.008844502581012016-03-04
20884450258006Elation™Merit Medical Systems, Inc.008844502580022016-03-04
20884450258037Elation™Merit Medical Systems, Inc.008844502580332016-03-03
20884450258068Elation™Merit Medical Systems, Inc.008844502580642016-03-04
20884450258082Elation™Merit Medical Systems, Inc.008844502580882016-03-04
10884450258115Elation™Merit Medical Systems, Inc.008844502581182016-03-03
10884450258146Elation™Merit Medical Systems, Inc.008844502581492016-03-04
20884450258129Elation™Merit Medical Systems, Inc.008844502581252016-03-04
20884450258136Elation™Merit Medical Systems, Inc.008844502581322016-03-04
00821925033160OlympusGyrus ACMI, LLCBD-400P-08802016-10-04
00821925033177OlympusGyrus ACMI, LLCBD-400P-10802016-10-04
00821925033184OlympusGyrus ACMI, LLCBD-400P-13802016-10-04
00821925033191OlympusGyrus ACMI, LLCBD-400P-15802016-10-04
00821925033207OlympusGyrus ACMI, LLCBD-400P-18802016-10-04
00821925033214OlympusGyrus ACMI, LLCBD-400P-20802016-10-04