Firefly Needleless Connector

Set, Administration, Intravascular

PuraCath Medical, Inc

The following data is part of a premarket notification filed by Puracath Medical, Inc with the FDA for Firefly Needleless Connector.

Pre-market Notification Details

Device IDK203796
510k NumberK203796
Device Name:Firefly Needleless Connector
ClassificationSet, Administration, Intravascular
Applicant PuraCath Medical, Inc 37600 Central Court, Suite 210 Newark,  CA  94560
ContactJulia Rasooly
CorrespondentJulia Rasooly
PuraCath Medical, Inc 37600 Central Court, Suite 210 Newark,  CA  94560
Product CodeFPA  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-12-28
Decision Date2021-07-30

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