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 IDK192313
510k NumberK192313
Device Name:Halo One Thin-Walled Guiding Sheath
ClassificationIntroducer, Catheter
Applicant C.R. Bard, Inc. Moyne Upper Enniscorthy,  IE
ContactElizabeth Delahunty
CorrespondentElizabeth Delahunty
C.R. Bard, Inc. Moyne Upper Enniscorthy,  IE
Product CodeDYB  
CFR Regulation Number870.1340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-08-26
Decision Date2019-12-19

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00801741161964 K192313 000
00801741161940 K192313 000
00801741161933 K192313 000
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00801741161919 K192313 000
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00801741161865 K192313 000
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00801741161803 K192313 000
00801741161957 K192313 000
00801741161971 K192313 000
10801741184809 K192313 000
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10801741184878 K192313 000
10801741184861 K192313 000
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10801741184847 K192313 000
10801741184830 K192313 000
10801741184823 K192313 000
10801741184816 K192313 000
00801741161797 K192313 000

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