AV FISTULA NEEDLE SET

Needle, Fistula

TERUMO AMERICA, INC.

The following data is part of a premarket notification filed by Terumo America, Inc. with the FDA for Av Fistula Needle Set.

Pre-market Notification Details

Device IDK771206
510k NumberK771206
Device Name:AV FISTULA NEEDLE SET
ClassificationNeedle, Fistula
Applicant TERUMO AMERICA, INC. 803 N. Front St. Suite 3 McHenry,  IL  60050
Product CodeFIE  
CFR Regulation Number876.5540 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1977-07-05
Decision Date1977-07-15

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