FDA.report

510(k) K260942

Device
AuST Steerable Sheath
Applicant
CenterPoint Systems, LLC
510(k) number
K260942
Product code
DYB
Decision
Substantially Equivalent (SESE)
Decision date
2026-04-07
Date received
2026-03-20
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
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Conner Johnson
Address
3338 Pkwy. Blvd. West Valley City UT US 84119 84119

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Other 510(k) Records For Product Code DYB

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K260459VANES Delivery System (VDS)Zoll Respicardia, Inc.2026-04-06
K260626Multiflex Steerable Sheath 17.5FVizaramed, Inc.2026-03-26
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K254236Peel-Away Introducer SheathVascuTech Medical, LLC2026-02-09
K253652Genie MAX Large Bore Introducer SheathCultiv8 1, LLC2026-01-22
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K253741V•Stick™ Vascular Access SetArgon Medical Devices, Inc.2025-12-15
K252309PerQseal IntroducersVivasure Medical Limited2025-10-23
K251838Introducer Sheath SetCardiocycle Medical(Suzhou) Co., Ltd.2025-10-21
K25276614Fr Low Profile Introducer KitAbiomed, Inc.2025-10-08