Plato 17 Microcatheter

Catheter, Percutaneous

Scientia Vascular LLC

The following data is part of a premarket notification filed by Scientia Vascular Llc with the FDA for Plato 17 Microcatheter.

Pre-market Notification Details

Device IDK210601
510k NumberK210601
Device Name:Plato 17 Microcatheter
ClassificationCatheter, Percutaneous
Applicant Scientia Vascular LLC 3487 West 2100 South Suite 100 West Valley City,  UT  84119
ContactAmy Mcmanus
CorrespondentPrithul Bom
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeDQY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2021-03-01
Decision Date2021-04-28

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