Stent, Metallic, Expandable, Duodenal

Device Code: 2174

Product Code(s): MUM

Device Classification Information

Device Type ID2174
Device NameStent, Metallic, Expandable, Duodenal
Regulation DescriptionEsophageal Prosthesis.
Regulation Medical SpecialtyGeneral & Plastic Surgery
Review PanelGastroenterology/Urology
Premarket Review Office Of Device Evaluation (ODE)
Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD)
Renal Devices Branch (RNDB)
Submission Type510(k)
CFR Regulation Number878.3610 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeMUM
GMP ExemptNo
Summary MRIneligible
Implanted DeviceYes
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID2174
DeviceStent, Metallic, Expandable, Duodenal
Product CodeMUM
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionEsophageal Prosthesis.
CFR Regulation Number878.3610 [🔎]
Premarket Reviews
ManufacturerDecision
COOK IRELAND LTD.
 
SUBSTANTIALLY EQUIVALENT
1
Device Problems
Stent
68
Break
44
Fracture
43
Activation, Positioning Or Separation Problem
38
Migration Or Expulsion Of Device
28
Adverse Event Without Identified Device Or Use Problem
22
Delivery System Failure
22
Positioning Problem
19
Activation Failure Including Expansion Failures
15
Premature Activation
11
Insufficient Information
9
Partial Blockage
8
Appropriate Term/Code Not Available
7
Catheter
6
Material Deformation
6
Detachment Of Device Or Device Component
5
Kinked
5
Difficult To Remove
4
Difficult Or Delayed Positioning
3
Occlusion Within Device
2
Material Frayed
1
Delivery System Issue, No Description
1
Device Deployer
1
Tip Breakage
1
Migration
1
Difficult To Advance
1
Safety Interlock
1
Positioning Failure
1
Material Fragmentation
1
Off-Label Use
1
Total Device Problems 375
TPLC Last Update: 2019-04-02 20:07:09

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