Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device esophageal dilator balloon with or without electrode sensors
Definition To dilate the lower esophageal sphincter of patients with Achalasia.
Product CodePID
Regulation Number 876.5980
Device Class 2


Premarket Reviews
ManufacturerDecision
CROSPON, LTD.
  SUBSTANTIALLY EQUIVALENT 1
WILSON-COOK MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 2 2
2020 4 4
2021 10 10
2022 9 9
2023 10 10
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 15 15
Burst Container or Vessel 13 13
Inflation Problem 2 2
Product Quality Problem 1 1
Use of Device Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Difficult to Advance 1 1
Material Twisted/Bent 1 1
Crack 1 1
Deflation Problem 1 1
Gradient Increase 1 1
Appropriate Term/Code Not Available 1 1
Break 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 16 16
Perforation of Esophagus 10 10
Perforation 5 5
No Consequences Or Impact To Patient 5 5
Unintended Radiation Exposure 2 2
Chest Pain 2 2
Hemorrhage/Bleeding 1 1
Pneumothorax 1 1
No Code Available 1 1
Syncope/Fainting 1 1
Asystole 1 1

-
-