Catheter, Multiple Lumen

Device Code: 5612

Product Code(s): GBP

Device Classification Information

Device Type ID5612
Device NameCatheter, Multiple Lumen
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 Two - Surgical (GSDB2)
Submission Type510(K) Exempt
CFR Regulation Number878.4200 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeGBP
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID5612
DeviceCatheter, Multiple Lumen
Product CodeGBP
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionIntroduction/drainage Catheter And Accessories.
CFR Regulation Number878.4200 [🔎]
Device Problems
Tip Breakage
1
Total Device Problems 1
TPLC Last Update: 2019-04-02 21:09:27

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