ASAHI CHIKAI 10 NEUROVASCULAR GUIDE WIRE

Guide, Wire, Catheter, Neurovasculature

ASAHI INTECC CO., LTD.

The following data is part of a premarket notification filed by Asahi Intecc Co., Ltd. with the FDA for Asahi Chikai 10 Neurovascular Guide Wire.

Pre-market Notification Details

Device IDK112979
510k NumberK112979
Device Name:ASAHI CHIKAI 10 NEUROVASCULAR GUIDE WIRE
ClassificationGuide, Wire, Catheter, Neurovasculature
Applicant ASAHI INTECC CO., LTD. 2500 RED HILL AVE, SUITE 210 Santa Ana,  CA  92705
ContactYoshi Terai
CorrespondentYoshi Terai
ASAHI INTECC CO., LTD. 2500 RED HILL AVE, SUITE 210 Santa Ana,  CA  92705
Product CodeMOF  
CFR Regulation Number870.1330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-10-06
Decision Date2011-12-01
Summary:summary

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