ASAHI PTCA GUIDE WIRE ASAHI SION BLUE 180CM ASAHI PTCA GUIDE WIRE ASAHI SION BLUE 3300CM ASAHI PTCA GUIDE WIRE ASAHI SIO

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 Blue 180cm Asahi Ptca Guide Wire Asahi Sion Blue 3300cm Asahi Ptca Guide Wire Asahi Sio.

Pre-market Notification Details

Device IDK122468
510k NumberK122468
Device Name:ASAHI PTCA GUIDE WIRE ASAHI SION BLUE 180CM ASAHI PTCA GUIDE WIRE ASAHI SION BLUE 3300CM ASAHI PTCA GUIDE WIRE ASAHI SIO
ClassificationWire, Guide, Catheter
Applicant ASAHI INTECC CO., LTD. 2500 RED HILL SUITE 210 Santa Ana,,  CA  92705
ContactYoshi Terai
CorrespondentYoshi Terai
ASAHI INTECC CO., LTD. 2500 RED HILL SUITE 210 Santa Ana,,  CA  92705
Product CodeDQX  
CFR Regulation Number870.1330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-08-13
Decision Date2013-03-08
Summary:summary

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