DYB · Introducer, Catheter

Cardiovascular · 21 CFR 870.1340 · Class 2

Overview

Product CodeDYB
Device NameIntroducer, Catheter
Regulation21 CFR 870.1340
Device ClassClass 2
Review PanelCardiovascular
3rd-Party ReviewableYes

Identification

A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.

Classification Rationale

Class II (performance standards).

Recent Cleared Devices (20 of 700)

Showing 20 most recent of 700 cleared devices.

RecordDevice NameApplicantDecision DateDecision
K254248Introducer Sheath SetCardiocycle Medical(Suzhou) Co., Ltd.Apr 23, 2026SESE
K254279Edwards eSheath+ introducer setEdwards LifesciencesApr 17, 2026SESE
K260091Aventus Introducer SheathInquis MedicalApr 13, 2026SESE
K260839Protaryx Transseptal Puncture Device (PTX2-001)Protaryx Medical, Inc.Apr 10, 2026SESE
K260942AuST Steerable SheathCenterPoint Systems, LLCApr 7, 2026SESE
K260459VANES Delivery System (VDS)Zoll Respicardia, Inc.Apr 6, 2026SESE
K260626Multiflex Steerable Sheath 17.5FVizaramed, Inc.Mar 26, 2026SESE
K260163AuST CSP IntroducerCenterPoint Systems, LLCFeb 19, 2026SESE
K254236Peel-Away Introducer SheathVascuTech Medical, LLCFeb 9, 2026SESE
K253652Genie MAX Large Bore Introducer SheathCultiv8 1, LLCJan 22, 2026SESE
K252508Intri26 Introducer SheathInari Medical, Inc.Dec 17, 2025SESE
K253741V•Stick™ Vascular Access SetArgon Medical Devices, Inc.Dec 15, 2025SESE
K252309PerQseal IntroducersVivasure Medical LimitedOct 23, 2025SESE
K251838Introducer Sheath SetCardiocycle Medical(Suzhou) Co., Ltd.Oct 21, 2025SESE
K25276614Fr Low Profile Introducer KitAbiomed, Inc.Oct 8, 2025SESE
K252441Primero Safe Access SystemSouth53, LLCSep 29, 2025SESE
K252227Pounce(TM) SheathSurmodics,Inc.Sep 24, 2025SESE
K252027Vertex(TM) CatheterJupiter EndovascularSep 12, 2025SESE
K252364Edwards eSheath Optima introducer setEdwards LifesciencesAug 29, 2025SESE
K251051AuST Steerable SheathCenterPoint Systems, LLCApr 30, 2025SESE

Top Applicants

Innolitics

Panel 1

/
Sort by
Ready

Predicate graph will load when search results are available.

Embedding visualization will load when search results are available.

PDF viewer will load when search results are available.

Loading panels...

Select an item from Submissions

Click any panel, subpart, regulation, product code, or device to see details here.

Section Matches

Results will appear here.

Product Code Matches

Results will appear here.

Special Control Matches

Results will appear here.

Loading collections...