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510(k) K011761

Device
MAC TWO-LUMEN CENTRAL VENOUS KIT WITH ARROWG ARD BLUE ANTIMICROBIAL SURFACE AND INTEGRAL HEMOSTASIS VALVE/SIDE PORT
Applicant
ARROW INTL., INC.
510(k) number
K011761
Product code
DYB  
Decision
Substantially Equivalent (SESE)
Decision date
2001-10-31
Date received
2001-06-06
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
No

Applicant Contact#

Contact
THOMAS D NICKEL
Address
2400 Bernville Rd. Reading PA US 19605 19605

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code DYB  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K261492FieldFlex Steerable SheathCenterPoint Systems, LLC2026-06-05
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

Legacy Summary#

summary