Plato MICROCATH 27B Microcatheter

Catheter, Intravascular, Diagnostic

Scientia Vascular LLC

The following data is part of a premarket notification filed by Scientia Vascular Llc with the FDA for Plato Microcath 27b Microcatheter.

Pre-market Notification Details

Device IDK170406
510k NumberK170406
Device Name:Plato MICROCATH 27B Microcatheter
ClassificationCatheter, Intravascular, Diagnostic
Applicant Scientia Vascular LLC 3487 West 2100 South Suite 100 West Valley City,  UT  84119
ContactDavid Sabodski
CorrespondentMark Job
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeDQO  
Subsequent Product CodeDQY
Subsequent Product CodeKRA
CFR Regulation Number870.1200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2017-02-10
Decision Date2017-04-18
Summary:summary

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