ASAHI SASUKE

Catheter, Percutaneous

Asahi Intecc Co., Ltd.

The following data is part of a premarket notification filed by Asahi Intecc Co., Ltd. with the FDA for Asahi Sasuke.

Pre-market Notification Details

Device IDK182844
510k NumberK182844
Device Name:ASAHI SASUKE
ClassificationCatheter, Percutaneous
Applicant Asahi Intecc Co., Ltd. 3-100 Akatsuki-cho Seto,  JP 489-0071
ContactYasuyuki Kawahara
CorrespondentCandace Cederman
CardioMed Device Consultants, LLC 1783 Forest Drive #254 Annapolis,  MD  21401
Product CodeDQY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-10-09
Decision Date2019-06-22

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