Pentaflush

Saline, Vascular Access Flush

PENTAFERTE ITALIA S.R.L.

The following data is part of a premarket notification filed by Pentaferte Italia S.r.l. with the FDA for Pentaflush.

Pre-market Notification Details

Device IDK214080
510k NumberK214080
Device Name:Pentaflush
ClassificationSaline, Vascular Access Flush
Applicant PENTAFERTE ITALIA S.R.L. Viale Piane Nocella, 23 Campli Teramo,  IT 64012
ContactRosa Di Gioia
CorrespondentLuca Giustini
PQE US 12300 Twinbrook Parkway, Suite 400 4th Floor Rockville,  MD  20852
Product CodeNGT  
CFR Regulation Number880.5200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-12-27
Decision Date2022-07-20

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