Catheter, Infusion

Device Code: 5690

Product Code(s): JCY

Device Classification Information

Device Type ID5690
Device NameCatheter, Infusion
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 CodeJCY
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID5690
DeviceCatheter, Infusion
Product CodeJCY
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionIntroduction/drainage Catheter And Accessories.
CFR Regulation Number878.4200 [🔎]
Device Problems
Insufficient Information
1
Material Integrity Problem
1
Connection Problem
1
Adverse Event Without Identified Device Or Use Problem
1
Total Device Problems 4
Recalls
Manufacturer Recall Class Date Posted
1
DePuy Mitek, Inc., A Johnson & Johnson Co.
II Feb-23-2018
TPLC Last Update: 2019-04-02 21:10:53

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