PVC Hydrophilic Urethral Catheter

Catheter, Straight

Chengdu Daxan Innovative Medical Tech. Co., Ltd

The following data is part of a premarket notification filed by Chengdu Daxan Innovative Medical Tech. Co., Ltd with the FDA for Pvc Hydrophilic Urethral Catheter.

Pre-market Notification Details

Device IDK212567
510k NumberK212567
Device Name:PVC Hydrophilic Urethral Catheter
ClassificationCatheter, Straight
Applicant Chengdu Daxan Innovative Medical Tech. Co., Ltd Unit 6, Building 1, No.18, North Bayi Road, Wenjiang District Chengdu,  CN 611135
ContactKevin Huang
CorrespondentKevin Huang
Chengdu Daxan Innovative Medical Tech. Co., Ltd Unit 6, Building 1, No.18, North Bayi Road, Wenjiang District Chengdu,  CN 611135
Product CodeEZD  
CFR Regulation Number876.5130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-08-16
Decision Date2022-12-07

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