510(k) K253741

Applicant Contact#

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
20886333227932	V-Stick Vascular Access Set	ARGON MEDICAL DEVICES, INC.	2026-03-20
20886333227925	V-Stick Vascular Access Set	ARGON MEDICAL DEVICES, INC.	2026-03-20
20886333227918	V- Stick Vascular Access Set	ARGON MEDICAL DEVICES, INC.	2026-03-20
20886333227901	V-Stick Vascular Access Set	ARGON MEDICAL DEVICES, INC.	2026-03-20
20886333227895	V-Stick Vascular Access Set	ARGON MEDICAL DEVICES, INC.	2026-03-20
20886333227888	V-Stick Vascular Access Set	ARGON MEDICAL DEVICES, INC.	2026-03-20
20886333227871	V-Stick Vascular Access Set	ARGON MEDICAL DEVICES, INC.	2026-03-20
20886333227864	V-Stick Vascular Access Set	ARGON MEDICAL DEVICES, INC.	2026-03-20
00886333227938	V-Stick Vascular Access Set	ARGON MEDICAL DEVICES, INC.	2026-03-20
00886333227921	V-Stick Vascular Access Set	ARGON MEDICAL DEVICES, INC.	2026-03-20
00886333227914	V- Stick Vascular Access Set	ARGON MEDICAL DEVICES, INC.	2026-03-20
00886333227907	V-Stick Vascular Access Set	ARGON MEDICAL DEVICES, INC.	2026-03-20
00886333227891	V-Stick Vascular Access Set	ARGON MEDICAL DEVICES, INC.	2026-03-20
00886333227884	V-Stick Vascular Access Set	ARGON MEDICAL DEVICES, INC.	2026-03-20
00886333227877	V-Stick Vascular Access Set	ARGON MEDICAL DEVICES, INC.	2026-03-20
00886333227860	V-Stick Vascular Access Set	ARGON MEDICAL DEVICES, INC.	2026-03-20

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K260606	Echo Large Bore Introducer Sheath	Echo Medical, LLC	2026-04-29
K254248	Introducer Sheath Set	Cardiocycle Medical(Suzhou) Co., Ltd.	2026-04-23
K254279	Edwards eSheath+ introducer set	Edwards Lifesciences	2026-04-17
K260091	Aventus Introducer Sheath	Inquis Medical	2026-04-13
K260839	Protaryx Transseptal Puncture Device (PTX2-001)	Protaryx Medical, Inc.	2026-04-10
K260942	AuST Steerable Sheath	CenterPoint Systems, LLC	2026-04-07
K260459	VANES Delivery System (VDS)	Zoll Respicardia, Inc.	2026-04-06
K260626	Multiflex Steerable Sheath 17.5F	Vizaramed, Inc.	2026-03-26
K260163	AuST CSP Introducer	CenterPoint Systems, LLC	2026-02-19
K254236	Peel-Away Introducer Sheath	VascuTech Medical, LLC	2026-02-09
K253652	Genie MAX Large Bore Introducer Sheath	Cultiv8 1, LLC	2026-01-22
K252508	Intri26 Introducer Sheath	Inari Medical, Inc.	2025-12-17
K252309	PerQseal Introducers	Vivasure Medical Limited	2025-10-23
K251838	Introducer Sheath Set	Cardiocycle Medical(Suzhou) Co., Ltd.	2025-10-21
K252766	14Fr Low Profile Introducer Kit	Abiomed, Inc.	2025-10-08