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510(k) K190855

Device
BD Acute Central Line
Applicant
Bard Access Systems, Inc. (Bard Has Joined BD)
510(k) number
K190855
Product code
FOZ  
Decision
Substantially Equivalent (SESE)
Decision date
2019-11-01
Date received
2019-04-02
Regulation
880.5200
Classification name
Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
Yes

Applicant Contact#

Contact
Sean J. Loring
Address
605 N. 5600 W. Salt Lake Ciy, UT US 84116 84116

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code FOZ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K260165Unimpregnated Central Venous CatheterSpectrum Vascular2026-08-10
K261041ClearSafe Closed SystemMedSource Labs, LLC2026-07-10
K260539MedSource QuickSafe™ Safety IV Catheter; MedSource PurSafe™ Safety IV CatheterMedSource Labs, LLC2026-07-09
K253235Introcan Safety® Deep Access XL IV CatheterB.Braun Medical, Inc.2026-05-15
K252137BD Insyte™ IV CatheterBecton Dickinson Infusion Therapy Systems, Inc.2026-04-02
K252513Polywin Safety (14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm; 20G x 45mm; 22G x 64mm; 22G x 45mm; 24G x 32mm; 24G x 14mm, 26G x 14mm); Polywin Safety Adva (20G x 45mm; 22G x 64mm; 22G x 45mm ; 24G x 32 mm; 24G x 14mm; 14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm, 26G x 14mm)Poly Medicure Limited2026-04-01
K252398SURFLO Hybria Closed System Safety IV CatheterTerumo Medical Products (Hangzhou) Co., Ltd.2025-12-17
K252677Polyshield Safety IV CathetersPoly Medicure Limited2025-11-05
K251422BD Saf-T-Intima™ Subcutaneous Catheter SystemBecton Dickinson Infusion Therapy Systems, Inc.2025-10-08
K243403BD Nexiva™ Closed IV Catheter SystemBecton Dickinson Infusion Therapy Systems, Inc.2025-07-25
K251155BD Cathena™ Safety IV CatheterBecton Dickinson Infusion Therapy Systems, Inc.2025-07-11
K251654BD Insyte™ Autoguard™ Shielded IV Catheter, BD Insyte™ Autoguard™ BC Shielded IV Catheter and BD Insyte™ Autoguard™ BC Pro Shielded IV CatheterBecton Dickinson Infusion Therapy Systems, Inc.2025-06-27
K250682BD Nexiva™ Diffusics™ Closed IV Catheter System and BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™ Needle-free ConnectorBecton Dickinson Infusion Therapy Systems, Inc.2025-06-03
K243105Ruby Intravascular CatheterVenocare, Inc.2025-05-16
K250292OSPREY Midline Closed IV Catheter System (OspreyEDC-F20)Skydance Vascular, Inc.2025-05-02

Legacy Summary#

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FDA Review#

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