ASAHI Caravel

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 Caravel.

Pre-market Notification Details

Device IDK152447
510k NumberK152447
Device Name:ASAHI Caravel
ClassificationCatheter, Percutaneous
Applicant ASAHI INTECC CO., LTD. 1703 WAKITA-CHO, MORIYAMA-KU Nagoya,  JP 463-0024
ContactYoshihiko Fukui
CorrespondentCandace Cederman
CARDIOMED DEVICE CONSULTANTS, LLC 5523 RESEARCH PARK DRIVE, SUITE 205 Baltimore,  MD  21228
Product CodeDQY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-08-27
Decision Date2016-01-22
Summary:summary

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