Asahi PTCA Guide Wire Asahi SION Series

Wire, Guide, Catheter

Asahi Intecc Co., LTD.

The following data is part of a premarket notification filed by Asahi Intecc Co., Ltd. with the FDA for Asahi Ptca Guide Wire Asahi Sion Series.

Pre-market Notification Details

Device IDK191464
501k NumberK191464
Device Name:Asahi PTCA Guide Wire Asahi SION Series
ClassificationWire, Guide, Catheter
Applicant Asahi Intecc Co., LTD. 3-100Akatsuki-cho Seto,  JP 489-0071
ContactYasuyuki Kawahara
CorrespondentCynthia Valenzuela
Asahi Intecc USA, Inc. 3002 Dow Ave, Suite 212 Tustin,  CA  92780
Product CodeDQX  
CFR Regulation Number870.1330 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyCardiovascular
501k Review PanelCardiovascular
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-06-03
Decision Date2019-11-21

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