I.V. Catheter

Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days

Jiangxi Sanxin Medtec Co., Ltd

The following data is part of a premarket notification filed by Jiangxi Sanxin Medtec Co., Ltd with the FDA for I.v. Catheter.

Pre-market Notification Details

Device IDK142797
510k NumberK142797
Device Name:I.V. Catheter
ClassificationCatheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Applicant Jiangxi Sanxin Medtec Co., Ltd No. 999, Fushan Road, Xiaolan Economic Development Nanchang,  CN 330200
ContactBingrong Liu
CorrespondentDiana Hong
Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai,  CN 200120
Product CodeFOZ  
CFR Regulation Number880.5200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-09-29
Decision Date2015-06-18
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20858835007947 K142797 000
20858835007930 K142797 000
20858835007923 K142797 000
10858835007919 K142797 000
20858835007060 K142797 000
10812460028633 K142797 000
10812460028619 K142797 000
16945060530023 K142797 000
16945060530016 K142797 000

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