Halo One Thin-Walled Guiding Sheath

Introducer, Catheter

C.R.Bard, Inc

The following data is part of a premarket notification filed by C.r.bard, Inc with the FDA for Halo One Thin-walled Guiding Sheath.

Pre-market Notification Details

Device IDK212708
510k NumberK212708
Device Name:Halo One Thin-Walled Guiding Sheath
ClassificationIntroducer, Catheter
Applicant C.R.Bard, Inc Moyne Upper Enniscorthy,  IE
ContactAnnmarie Fitzgerald
CorrespondentAnnmarie Fitzgerald
C.R.Bard, Inc Moyne Upper Enniscorthy,  IE
Product CodeDYB  
CFR Regulation Number870.1340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-08-26
Decision Date2021-09-23

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