TERUMO SURFLO FLEX I.V. CATHETER AND TERUMO SURFLASH I.V. CATHETER

Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days

TERUMO MEDICAL CORP.

The following data is part of a premarket notification filed by Terumo Medical Corp. with the FDA for Terumo Surflo Flex I.v. Catheter And Terumo Surflash I.v. Catheter.

Pre-market Notification Details

Device IDK991406
510k NumberK991406
Device Name:TERUMO SURFLO FLEX I.V. CATHETER AND TERUMO SURFLASH I.V. CATHETER
ClassificationCatheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Applicant TERUMO MEDICAL CORP. 125 BLUE BALL RD. Elkton,  MD  21921
ContactKristine Wagner
CorrespondentKristine Wagner
TERUMO MEDICAL CORP. 125 BLUE BALL RD. Elkton,  MD  21921
Product CodeFOZ  
CFR Regulation Number880.5200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-04-22
Decision Date1999-06-16
Summary:summary

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