R2P Destination Slender Guiding Sheath

Introducer, Catheter

Terumo Medical Corporation

The following data is part of a premarket notification filed by Terumo Medical Corporation with the FDA for R2p Destination Slender Guiding Sheath.

Pre-market Notification Details

Device IDK193125
510k NumberK193125
Device Name:R2P Destination Slender Guiding Sheath
ClassificationIntroducer, Catheter
Applicant Terumo Medical Corporation 950 Elkton Blvd. Elkton,  MD  21921
ContactLiang Lu
CorrespondentLiang Lu
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 Received2019-11-12
Decision Date2020-01-06

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