TERUMO SURSHIELD SAFETY I.V. CATHETER (18G X 51MM & 20G X 51MM SIZES)

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

TERUMO CORP.

The following data is part of a premarket notification filed by Terumo Corp. with the FDA for Terumo Surshield Safety I.v. Catheter (18g X 51mm & 20g X 51mm Sizes).

Pre-market Notification Details

Device IDK090973
510k NumberK090973
Device Name:TERUMO SURSHIELD SAFETY I.V. CATHETER (18G X 51MM & 20G X 51MM SIZES)
ClassificationCatheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Applicant TERUMO CORP. 125 BLUE BALL RD. Elkton,  MD  21921
ContactLynne Witkowski
CorrespondentLynne Witkowski
TERUMO CORP. 125 BLUE BALL RD. Elkton,  MD  21921
Product CodeFOZ  
CFR Regulation Number880.5200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-04-06
Decision Date2009-05-01
Summary:summary

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