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510(k) K212708

Device
Halo One Thin-Walled Guiding Sheath
Applicant
C.R.Bard, Inc
510(k) number
K212708
Product code
DYB  
Decision
Substantially Equivalent (SESE)
Decision date
2021-09-23
Date received
2021-08-26
Regulation
870.1340
Classification name
Introducer, Catheter
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Annmarie Fitzgerald
Address
Moyne Upper Enniscorthy IE

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code DYB  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K253526NAMIC Dilator and SheathMedline Industries, LP2026-07-29
K261529Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit / Microintroducer Kit (SIS05C); Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set / Microintroducer Kit / Microintroducer Kit (IS01); Introducer Kit / Microintroducer Kit / Introducer Set /Microintroducer Set / Micro Introducer Sheath Set / Introducer Sheath Set (NIS04)Hartman Medical Group, LLC2026-07-06
K261242SimplGuidePendracare2026-06-25
K261950Health Line Tearaway IntroducerHealth Line International Corporation2026-06-22
K261492FieldFlex Steerable SheathCenterPoint Systems, LLC2026-06-05
K260606Echo Large Bore Introducer SheathEcho Medical, LLC2026-04-29
K254248Introducer Sheath SetCardiocycle Medical(Suzhou) Co., Ltd.2026-04-23
K254279Edwards eSheath+ introducer setEdwards Lifesciences2026-04-17
K260091Aventus Introducer SheathInquis Medical2026-04-13
K260839Protaryx Transseptal Puncture Device (PTX2-001)Protaryx Medical, Inc.2026-04-10
K260942AuST Steerable SheathCenterPoint Systems, LLC2026-04-07
K260459VANES Delivery System (VDS)Zoll Respicardia, Inc.2026-04-06
K260626Multiflex Steerable Sheath 17.5FVizaramed, Inc.2026-03-26
K260163AuST CSP IntroducerCenterPoint Systems, LLC2026-02-19
K254236Peel-Away Introducer SheathVascuTech Medical, LLC2026-02-09

Legacy Summary#

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FDA Review#

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