FDA.reportPublic FDA data

510(k) K081515

Device
NEOMED DUAL LUMEN UMBILICAL CATHETER, MODELS S2UVC4.0, S2UVC5.0
Applicant
Neomed, Inc.
510(k) number
K081515
Product code
FOS
Decision
Substantially Equivalent (SESE)
Decision date
2008-07-21
Date received
2008-05-30
Regulation
880.5200
Classification name
Catheter, Umbilical Artery
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
PENNY NORTHCUTT
Address
717 Lakeglen Dr. Swanee GA US 30024 30024

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code FOS#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K201697Umbilical Vessels CatheterHaolang Medical USA Corporation2021-05-06
K130725MODIFIED ARGYLE POLYURETHANE UMBILICAL VESSEL CATHETER 2.5FR, 3.5FR, 5 FR.Covidien Lp, Formerly Registered AS Kendall2013-04-17
K120304FOOTPRINT MEDICAL POLYURETHANE UMBILICAL CATHETERFootprint Medical, Inc.2012-03-01
K091213FOOTPRINT MEDICAL UMBILICAL CATHETER, DUAL LUMENFootprint Medical2009-09-25
K091214FOOTPRINT MEDICAL SILICONE UMBILICAL CATHETERFootprint Medical2009-09-25
K073596NEOMED SINGLE LUMEN UMBILICAL CATHETERNeomed, Inc.2008-02-22
K981630VYGON DOUBLE LUMEN UMBILICAL CATHETERSchiff & Co.1998-10-01
K963972NEO-CARE DUAL LUMEN UMBILICAL CATHETERKlein-Baker Medical, Inc.1996-12-24
K954300ARGYLE NEO-SERT HYDROPHILIC POLYURETHANE UMBILICAL VESSEL CATHETER INSERTION TRAYSherwood Medical Co.1995-12-13
K951738ARGYLE NEO-SERT TRIPLE LUMEN UMBILICAL VESSEL CATHETERSherwood Medical Co.1995-09-29
K951737ARGYLE NEO-SERT TRIPLE LUMEN UMBILICAL VESSEL CATHETER INSERTION TRAYSherwood Medical Co.1995-09-28
K942353CENTURION UMBILICAL CATHETERTri-State Hospital Supply Corp.1995-08-15
K941429IV CATHETER AND OBTURATORBecton Dickinson Vascular Access, Inc.1995-01-04
K942827SENTRY INSERTION TRAYSentry Medical Products, Inc.1994-11-02
K941814ARGYLE DUAL LUMEN UMBILICAL VESSEL CATHETERSherwood Medical Co.1994-09-30