HEARTRAIL III GUIDING CATHETER

Catheter, Intravascular, Diagnostic

TERUMO CORP.

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

Pre-market Notification Details

Device IDK092372
510k NumberK092372
Device Name:HEARTRAIL III GUIDING CATHETER
ClassificationCatheter, Intravascular, Diagnostic
Applicant TERUMO CORP. 950 Elkton Blvd. Elkton,  MD  21921
ContactMark Unterreiner
CorrespondentMark Job
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeDQO  
CFR Regulation Number870.1200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2009-08-05
Decision Date2009-09-11
Summary:summary

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