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510(k) K172266

Device
Dynarex Three-Way Stopcock
Applicant
Dynarex Corporation
510(k) number
K172266
Product code
FMG  
Decision
Substantially Equivalent (SESE)
Decision date
2018-03-14
Date received
2017-07-27
Regulation
880.5440
Classification name
Stopcock, I.v. Set
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
Pablo Martinez
Address
10 Glenshaw St. Orangeburg NY US 10962 10962

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code FMG  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K242255Qitexio® 4-Way Stopcock (QIT014)Medex2025-04-29
K223499Three Way Stop CockM/S Romsons International2023-07-21
K223175lntravascular Administration Sets with Stopcock and ManifoldBaxter Healthcare Corporation2023-03-10
K211204SafePort(TM) Manifold (or Stopcock)Elcam Medical Acal2022-09-15
K210516Clicky CrossYomura Technologies, Inc.2022-05-16
K190539TurnSignal Stopcocks Sterile, TurnSignal Stopcocks Buld Non Sterile, TurnSignal Stopcocks with Manifolds Sterile, TurnSignal Stopcocks with Manifolds Bulk Non SterileMonumedical, LLC2019-10-22
K190489Elcam Stopcocks and ManifoldsElcam Medical Acal2019-04-23
K141254ELCAM STOPCOCKS AND MANIFOLDSElcam Medical Acal2014-07-30
K123084DISPOSABLE HIGH PRESSURE STOPCOCK/MANIFOLD MODEL HP STOPCOCK, MP STOPCOCK, HP MANIFOLD, PHP MANIFOLDElcam Medical Acal2013-05-23
K130245LARGE BORE STOPCOCK WITH ROTATING MALE LUER LOCK/LARGE BORE STOPCOCK WITH EXTENSION SET, GANG LARGE BORE STOPCOCK MANIFOBaxter Healthcare Corp2013-03-01
K082110DUAL SYRINGE HOLDERSurgin Surgical Instrumentation, Inc.2009-06-17
K082836ICU MEDICAL UNIVERSAL SINGLE-USE SPIKESIcu Medical, Inc.2009-02-25
K082106ELCAM ANTIMICROBIAL CLOSED STOPCOCKS (DSS AND TSS)Elcam Medical Acal2008-10-02
K080077CLAVE STOPCOCKIcu Medical, Inc.2008-02-13
K071400SMARTSITE STOPCOCKCardinal Health, Alaris Products2007-12-14

Legacy Summary#

summary

FDA Review#

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