Catheter, Cholangiography

Device Code: 5618

Product Code(s): GBZ

Device Classification Information

Device Type ID5618
Device NameCatheter, Cholangiography
Regulation DescriptionIntroduction/drainage Catheter And Accessories.
Regulation Medical SpecialtyGeneral & Plastic Surgery
Review PanelGeneral & Plastic Surgery
Premarket Review Office Of Device Evaluation (ODE)
Division Of Surgical Devices (DSD)
General Surgery Devices Branch One - Light Based/Laser (GSDB1)
Submission Type510(K) Exempt
CFR Regulation Number878.4200 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeGBZ
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID5618
DeviceCatheter, Cholangiography
Product CodeGBZ
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionIntroduction/drainage Catheter And Accessories.
CFR Regulation Number878.4200 [🔎]
Device Problems
Material Separation
9
Device Contamination With Chemical Or Other Material
5
Misassembled
5
Unraveled Material
3
Break
3
Fluid Leak
3
Split
2
Device Markings / Labelling Problem
2
Device Contaminated During Manufacture Or Shipping
2
Product Quality Problem
2
Migration Or Expulsion Of Device
2
Physical Resistance
1
Device Operates Differently Than Expected
1
Material Integrity Problem
1
Adverse Event Without Identified Device Or Use Problem
1
Occlusion Within Device
1
Component Missing
1
Structural Problem
1
Catheter
1
Material Deformation
1
Detachment Of Device Component
1
Leak / Splash
1
Sticking
1
Folded
1
Material Protrusion / Extrusion
1
Complete Blockage
1
Material Fragmentation
1
Unsealed Device Packaging
1
Detachment Of Device Or Device Component
1
Improper Flow Or Infusion
1
Needle
1
Insufficient Information
1
Device Slipped
1
Material Perforation
1
Crack
1
Total Device Problems 62
Recalls
Manufacturer Recall Class Date Posted
1
American Catheter Corp
II Jul-22-2015
2
Atrium Medical Corporation
II Dec-06-2018
3
Atrium Medical Corporation
II Feb-16-2017
4
Atrium Medical Corporation
II Nov-16-2016
5
Atrium Medical Corporation
II Aug-05-2015
6
Cook Inc.
II Jul-18-2015
7
Teleflex Medical
II Jun-12-2014
TPLC Last Update: 2019-04-02 21:09:34

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.