ASAHI PTCA GUIDE WIRE, X-TREME

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, X-treme.

Pre-market Notification Details

Device IDK072431
510k NumberK072431
Device Name:ASAHI PTCA GUIDE WIRE, X-TREME
ClassificationWire, Guide, Catheter
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 CodeDQX  
CFR Regulation Number870.1330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-08-29
Decision Date2007-09-26
Summary:summary

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