FDA.report

510(k) K260091

Device
Aventus Introducer Sheath
Applicant
Inquis Medical
510(k) number
K260091
Product code
DYB
Decision
Substantially Equivalent (SESE)
Decision date
2026-04-13
Date received
2026-01-12
Regulation
870.1340
Classification name
Introducer, Catheter
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Zachary Woodson
Address
1530 O'Brien Dr. Suite A Menlo Park CA US 94025 94025

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

510(k)DeviceApplicantDecision date
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
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
K253652Genie MAX Large Bore Introducer SheathCultiv8 1, LLC2026-01-22
K252508Intri26 Introducer SheathInari Medical, Inc.2025-12-17
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