Deltaven Fast Flash Closed I.V. Catheter Systems

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

Delta Med Spa

The following data is part of a premarket notification filed by Delta Med Spa with the FDA for Deltaven Fast Flash Closed I.v. Catheter Systems.

Pre-market Notification Details

Device IDK200373
510k NumberK200373
Device Name:Deltaven Fast Flash Closed I.V. Catheter Systems
ClassificationCatheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Applicant Delta Med Spa Via Guido Rossa, 20 Viadana,  IT 46019
ContactRaschi Olga
CorrespondentRoger Gray
Donawa Lifescience Consulting Srl Piazza Albania, 10 Roma,  IT 00153
Product CodeFOZ  
CFR Regulation Number880.5200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-02-14
Decision Date2020-08-26

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