Glidesheath

Introducer, Catheter

TERUMO MEDICAL CORPORATION

The following data is part of a premarket notification filed by Terumo Medical Corporation with the FDA for Glidesheath.

Pre-market Notification Details

Device IDK152173
510k NumberK152173
Device Name:Glidesheath
ClassificationIntroducer, Catheter
Applicant TERUMO MEDICAL CORPORATION 950 ELKTON BLVD. Elkton,  MD  21921
ContactErin Doyle
CorrespondentErin Doyle
TERUMO MEDICAL CORPORATION 950 ELKTON BLVD. Elkton,  MD  21921
Product CodeDYB  
CFR Regulation Number870.1340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-08-04
Decision Date2015-12-01
Summary:summary

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