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510(k) K103825

Device
V-GO INSULIN DELIVERY SYSTEM
Applicant
VALERITAS, INC.
510(k) number
K103825
Product code
LZG  
Decision
Substantially Equivalent (SESE)
Decision date
2011-02-23
Date received
2010-12-30
Regulation
880.5725
Classification name
Pump, Infusion, Insulin
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
SCOTT HUIE
Address
800 Boston Tpke. Shrewsbury MA US 01545 01545

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LZG  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K253534Pivot Insulin Delivery SystemModular Medical2026-04-08
K240158Modular Medical MODD1 Insulin Delivery SystemModular Medical, Inc.2024-09-04
K241622Extended Reservoir; MiniMed ReservoirMedtronic Minimed2024-07-02
K223372Omnipod GO Insulin Delivery DeviceInsulet Corporation2023-04-24
K210714Extended ReservoirMedtronic Minimed, Inc.2022-04-06
K211575Omnipod® Insulin Management System, Omnipod DASH® Insulin Management SystemInsulet Corporation2021-08-13
K192659Omnipod Insulin Management System, Omnipod DASH Insulin Management SystemInsulet Corporation2019-10-21
K182630Omnipod Insulin Management System, Omnipod DASH Insulin Management SystemInsulet Corporation2019-01-08
K180045Omnipod DASH Insulin Management SystemInsulet Corporation2018-06-01
K162296OmniPod Insulin Management SystemInsulet Corporation2017-04-18
K162080t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device UpdaterTandem Diabetes Care, Inc.2016-10-25
K160056t:slim Insulin Delivery SystemTandem Diabetes Care, Inc.2016-07-25
K160482t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device UpdaterTandem Diabetes Care, Inc.2016-07-13
K160252OmniPod Insulin Management SystemInsulet Corporation2016-04-27
K143189t:flex Insulin Delivery SystemTandem Diabetes Care, Inc.2015-01-09

Legacy Summary#

summary

FDA Review#

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