Introducer Set

Introducer, Catheter

Shanghai Kindly Medical Instruments Co., Ltd.

The following data is part of a premarket notification filed by Shanghai Kindly Medical Instruments Co., Ltd. with the FDA for Introducer Set.

Pre-market Notification Details

Device IDK180178
510k NumberK180178
Device Name:Introducer Set
ClassificationIntroducer, Catheter
Applicant Shanghai Kindly Medical Instruments Co., Ltd. No. 925, Jinyuan Yi Road Shanghai,  CN 201803
ContactXu Jianhai
CorrespondentXu Jianhai
Shanghai Kindly Medical Instruments Co., Ltd. No. 925, Jinyuan Yi Road Shanghai,  CN 201803
Product CodeDYB  
CFR Regulation Number870.1340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-01-22
Decision Date2018-09-10
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00850004162200 K180178 000
26950900923733 K180178 000
26950900923719 K180178 000
26950900923696 K180178 000
26950900923542 K180178 000
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26950900921142 K180178 000
26950900921135 K180178 000
26950900921128 K180178 000
26950900921111 K180178 000
26950900920565 K180178 000
26950900920312 K180178 000
26950900920305 K180178 000
26950900926291 K180178 000
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00850004162194 K180178 000
00850004162187 K180178 000
00850004162170 K180178 000
00850004162163 K180178 000
00850004162156 K180178 000
00850004162149 K180178 000
00850004162132 K180178 000
00850004162125 K180178 000
26950900961582 K180178 000
26950900926390 K180178 000
26950900926376 K180178 000
26950900926352 K180178 000
06950900920295 K180178 000

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