Progreat

Catheter, Intravascular, Diagnostic

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 Progreat.

Pre-market Notification Details

Device IDK170223
510k NumberK170223
Device Name:Progreat
ClassificationCatheter, Intravascular, Diagnostic
Applicant ASHITAKA FACTORY OF TERUMO CORPORATION 150 MAIMAIGI-CHO Fujinomiya,  JP 418-0015
ContactLauren P. Nitahara
CorrespondentLauren P. Nitahara
TERUMO MEDICAL CORPORATION 265 DAVIDSON AVENUE, SUITE 320 Somerset,  NJ  08873
Product CodeDQO  
CFR Regulation Number870.1200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-01-25
Decision Date2017-07-21
Summary:summary

Trademark Results [Progreat]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PROGREAT
PROGREAT
87570127 5418190 Live/Registered
Terumo Kabushiki Kaisha
2017-08-15
PROGREAT
PROGREAT
78514677 3097500 Live/Registered
Terumo Kabushiki Kaisha
2004-11-10
PROGREAT
PROGREAT
76412503 not registered Dead/Abandoned
Tsubakimoto Chain Co.
2002-05-28
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