Clarus Peel-Away Introducer Sheath

Endoscope, Neurological

Clarus Medical, LLC

The following data is part of a premarket notification filed by Clarus Medical, Llc with the FDA for Clarus Peel-away Introducer Sheath.

Pre-market Notification Details

Device IDK200925
510k NumberK200925
Device Name:Clarus Peel-Away Introducer Sheath
ClassificationEndoscope, Neurological
Applicant Clarus Medical, LLC 13355 10th Ave N Suite 110 Plymouth,  MN  55441
ContactMark F. Brown
CorrespondentMark F. Brown
Clarus Medical, LLC 13355 10th Ave N Suite 110 Plymouth,  MN  55441
Product CodeGWG  
CFR Regulation Number882.1480 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-04-07
Decision Date2021-03-18

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.