Arterial Catheter

Catheter, Percutaneous

Haolang Medical USA Corporation

The following data is part of a premarket notification filed by Haolang Medical Usa Corporation with the FDA for Arterial Catheter.

Pre-market Notification Details

Device IDK201726
510k NumberK201726
Device Name:Arterial Catheter
ClassificationCatheter, Percutaneous
Applicant Haolang Medical USA Corporation 1100 Bellevue Way NE 8A-533 Bellevue,  WA  98004
ContactLisa Xu
CorrespondentLisa Xu
Haolang Medical USA Corporation 1100 Bellevue Way NE 8A-533 Bellevue,  WA  98004
Product CodeDQY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-23
Decision Date2021-07-07

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