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FPK — Tubing, Fluid Delivery Class II

FDA Device Classification

Classification Details

Product Code
FPK
Device Class
Class II
Regulation Number
880.5440
Submission Type
Review Panel
HO
Medical Specialty
General Hospital
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K131517medrad, inc. / bayer medical careMEDRAD TWIST & GO HIGH PRESSURE CONNECTOR TUBINGAugust 2, 2013
K063114coeurDISPOSABLE TRANSFER SETS WITH AND WITHOUT SWABBABLE VALVES AND/OR CHECK VALVESFebruary 9, 2007
K063239hospiraLIFESHIELD LATEX-FREE GRAVITECH FLOW CONTROLLER I.V. SETS, MODELS 17528, 17527, December 11, 2006
K052431medtronic minimedMEDTRONIC MINIMED LEAPFROG II INFUSION SET, MODELS MMT-801S1, MMT-801L1, MMT-801November 29, 2005
K041178e-z-emEMPOWER TRANSFER SET, (CAT. NO. 7725)July 16, 2004
K031808medradMEDRAD SWABBABLE VALVE TRANSFER SETJuly 11, 2003
K022431medradMEDRAD TRANSFER SETSeptember 5, 2002
K965208medtronic minimedPOLYFIN EXTENSION SET, MODELS 126 AND 128February 26, 1997
K953864degania siliconeSILCLEAR TUBING (MODIFICATION)November 6, 1995
K950508sysmexSYSMEX SF-3000November 3, 1995
K952243coast medicalEXTENSION SET/I.V. SETJuly 26, 1995
K952663distronic sterile products60 MICRO VOLUME EXTENSION SET W/.22 MICRON FILTER, 21 EXTENSION SET W/1.2 MIVTONJuly 14, 1995
K950861organonRECONSTITUTION ACCESSOREISMay 26, 1995
K933524mediziv medical products 1987EXTENTION SETMay 23, 1995
K950200scott/ross designsIVIDMarch 24, 1995
K943992degania siliconeSILCLEAR TUBINGMarch 16, 1995
K943206prn servicesVARIOUS TUBINGMarch 9, 1995
K945184distronic sterile productsINTRAVASCULAR ADMINISTRATION SETFebruary 8, 1995
K941214abbott mfgLIFESHIELD EXTENSION SETOctober 3, 1994
K935642evans medicalEVANS MEDICAL EXTENSION SETSJanuary 28, 1994