FDA.report

Product code DYB

Current FDA Classification

Device name
Introducer, Catheter
Medical specialty
Cardiovascular
Device class
2
Regulation number
870.1340
Review panel
CV
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
Y
Summary malfunction reporting
Eligible

Related 510(k) Records

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
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
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
K252441Primero Safe Access SystemSouth53, LLC2025-09-29
K252227Pounce(TM) SheathSurmodics,Inc.2025-09-24
K252027Vertex(TM) CatheterJupiter Endovascular2025-09-12
K252364Edwards eSheath Optima introducer setEdwards Lifesciences2025-08-29
K251051AuST Steerable SheathCenterPoint Systems, LLC2025-04-30
K250909Prelude Wave Hydrophilic Sheath IntroducerMerit Medical Systems, Inc.2025-04-25
K243954PeriCross™ Epicardial Access KitCirca Scientific, Inc.2025-04-24
K244046Edwards eSheath Optima introducer setEdwards Lifesciences2025-03-27
K243928ViaOne Epicardial Access SystemCardiovia , Ltd.2025-03-20
K250468iSLEEVE Introducer SetBoston Scientific2025-03-20
K250439Catapult Guide Sheath; 4F; 15cm (US-34015-F-ST-H); Catapult Guide Sheath; 4F; 45cm (US-34045-F-ST-H); Catapult Guide Sheath; 4F; 60cm (US-34060-F-ST-H); Catapult Guide Sheath; 4F; 90cm (US-34090-F-ST-H); Catapult Guide Sheath; 4F; 130cm (US-34130-F-ST-H); Catapult Guide Sheath; 5F; 15cm (US-35015-F-ST-H); Catapult Guide Sheath; 5F; 45cm (US-35045-F-ST-H); Catapult Guide Sheath; 5F; 45cm; Hockey Stick (US-35045-F-HS-H); Catapult Guide Sheath; 5F; 45cm; Multipurpose (US-35045-F-MP-H); CaContract Medical International, GmbH2025-03-16
K243493Agilis NxT Steerable Introducer Dual-ReachABBOTT MEDICAL2024-12-13
K242520Element Vascular Access SystemPenumbra, Inc.2024-11-20
K242756Introducer Sheath (PFlexi00L065, PFlexi00L070, PFlexi00L075, PFlexi00L080, PFlexi00L090, PFlexi30L065, PFlexi30L070, PFlexi30L075, PFlexi30L080, PFlexi30L090, PFlexi45L065, PFlexi45L070, PFlexi45L075, PFlexi45L080, PFlexi45L090, PFlexi60L065, PFlexi60L070, PFlexi60L075, PFlexi60L080, PFlexi60L090)Pulnovo Medical (Wuxi) Co., Ltd.2024-11-08

Related GUDID Devices

Primary DIBrandCompanyPublished
20886333227871V-Stick Vascular Access SetARGON MEDICAL DEVICES, INC.2026-03-20
20886333227888V-Stick Vascular Access Set ARGON MEDICAL DEVICES, INC.2026-03-20
20886333227895V-Stick Vascular Access SetARGON MEDICAL DEVICES, INC.2026-03-20
20886333227901V-Stick Vascular Access Set ARGON MEDICAL DEVICES, INC.2026-03-20
20886333227918V- Stick Vascular Access SetARGON MEDICAL DEVICES, INC.2026-03-20
20886333227925V-Stick Vascular Access SetARGON MEDICAL DEVICES, INC.2026-03-20
20886333227932V-Stick Vascular Access SetARGON MEDICAL DEVICES, INC.2026-03-20
20886333227864V-Stick Vascular Access SetARGON MEDICAL DEVICES, INC.2026-03-20
00813502010411Impella RP Flex Introducer KitAbiomed, Inc.2026-03-11
00813502011685Abiomed Impella CP 14Fr Introducer KitAbiomed, Inc.2026-03-11
00813502011692Abiomed Impella CP 14Fr Introducer Kit Abiomed, Inc.2026-03-11
20801902225508ARROWTELEFLEX INCORPORATED2026-03-11
20801902225546ARROWTELEFLEX INCORPORATED2026-03-11
00840479401263enableCV Introducer SheathENABLECV INC.2026-02-26
20884450115804Prelude IDeal™Merit Medical Systems, Inc.2026-02-25
20884450113992Prelude IDeal™Merit Medical Systems, Inc.2026-02-25
00884450489642Prelude SNAP™Merit Medical Systems, Inc.2026-02-21
30884908188456MICRO-STICK SETMedical Components, Inc.2026-02-19
30884908188463MICRO-STICK SETMedical Components, Inc.2026-02-19
50884908188474MICRO-STICK SETMedical Components, Inc.2026-02-19
50884908188481MICRO-STICK SETMedical Components, Inc.2026-02-19
20801902225362ARROWTELEFLEX INCORPORATED2026-02-17
50382903829120Insyte AutoguardBECTON, DICKINSON AND COMPANY2026-02-13
30382903829249Insyte AutoguardBECTON, DICKINSON AND COMPANY2026-02-13
50382903829472Insyte AutoguardBECTON, DICKINSON AND COMPANY2026-02-13
50382903829540Insyte AutoguardBECTON, DICKINSON AND COMPANY2026-02-13
20801902225133ARROWTELEFLEX INCORPORATED2026-02-13
20801902225171ARROWTELEFLEX INCORPORATED2026-02-13
00884450465981HeartSpan®Merit Medical Systems, Inc.2026-02-07
20884450846470Prelude IDeal™Merit Medical Systems, Inc.2026-02-06