FineCross M3

Catheter, Percutaneous

Ashitaka Factory Of Terumo Corporation

The following data is part of a premarket notification filed by Ashitaka Factory Of Terumo Corporation with the FDA for Finecross M3.

Pre-market Notification Details

Device IDK203521
510k NumberK203521
Device Name:FineCross M3
ClassificationCatheter, Percutaneous
Applicant Ashitaka Factory Of Terumo Corporation 150 Maimaigi-cho Fujinomiya,  JP 418-0015
ContactVaibhav Sivaramakrishan
CorrespondentVaibhav Sivaramakrishan
Terumo Medical Corporation 265 Davidson Ave., Suite 320 Somerset,  NJ  08873
Product CodeDQY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-12-01
Decision Date2021-03-03

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.