HEARTRAIL III GUIDING CATHETER

Catheter, Intravascular, Diagnostic

TERUMO Corporation

The following data is part of a premarket notification filed by Terumo Corporation with the FDA for Heartrail Iii Guiding Catheter.

Pre-market Notification Details

Device IDK113335
510k NumberK113335
Device Name:HEARTRAIL III GUIDING CATHETER
ClassificationCatheter, Intravascular, Diagnostic
Applicant TERUMO Corporation 44-1, 2-CHOME HATAGAYA Shibuya-ku Tokyo,  JP 151-0072
ContactMark Unterreiner
CorrespondentMark Unterreiner
TERUMO Corporation 44-1, 2-CHOME HATAGAYA Shibuya-ku Tokyo,  JP 151-0072
Product CodeDQO  
CFR Regulation Number870.1200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-11-14
Decision Date2012-07-16
Summary:summary

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