FPK · Class II · 21 CFR 880.5440

FDA Product Code FPK: Tubing, Fluid Delivery

Leading manufacturers include Churchill Corp., Clinical Connections, Inc. and Degania Silicone , Ltd..

64
Total
64
Cleared
83d
Avg days
1977
Since

FDA 510(k) Cleared Tubing, Fluid Delivery Devices (Product Code FPK)

64 devices
1–24 of 64
Cleared Aug 02, 2013
MEDRAD TWIST & GO HIGH PRESSURE CONNECTOR TUBING
K131517
Medrad, Inc. / Bayer Medical Care, Inc.
General Hospital · 66d
Cleared Feb 09, 2007
DISPOSABLE TRANSFER SETS WITH AND WITHOUT SWABBABLE VALVES AND/OR CHECK VALVES
K063114
Coeur, Inc.
General Hospital · 121d
Cleared Dec 11, 2006
LIFESHIELD LATEX-FREE GRAVITECH FLOW CONTROLLER I.V. SETS, MODELS 17528, 17527, 17525 & 17526
K063239
Hospira, Inc.
General Hospital · 46d
Cleared Nov 29, 2005
MEDTRONIC MINIMED LEAPFROG II INFUSION SET, MODELS MMT-801S1, MMT-801L1, MMT-801S2, MMT-801L2, MMT-803S1
K052431
Medtronic Minimed
General Hospital · 84d
Cleared Jul 16, 2004
EMPOWER TRANSFER SET, (CAT. NO. 7725)
K041178
E-Z-Em, Inc.
General Hospital · 72d
Cleared Jul 11, 2003
MEDRAD SWABBABLE VALVE TRANSFER SET
K031808
Medrad, Inc.
General Hospital · 29d
Cleared Sep 05, 2002
MEDRAD TRANSFER SET
K022431
Medrad, Inc.
General Hospital · 42d
Cleared Feb 26, 1997
POLYFIN EXTENSION SET, MODELS 126 AND 128
K965208
Medtronic Minimed
General Hospital · 61d
Cleared Nov 06, 1995
SILCLEAR TUBING (MODIFICATION)
K953864
Degania Silicone , Ltd.
General Hospital · 91d
Cleared Nov 03, 1995
SYSMEX SF-3000
K950508
Sysmex Corp.
Hematology · 270d
Cleared Jul 26, 1995
EXTENSION SET/I.V. SET
K952243
Coast Medical, Inc.
General Hospital · 75d
Cleared Jul 14, 1995
60 MICRO VOLUME EXTENSION SET W/.22 MICRON FILTER, 21 EXTENSION SET W/1.2 MIVTON GILYRT, INJ. SITE, CLAMP
K952663
Distronic Sterile Products, Inc.
General Hospital · 32d
Cleared May 26, 1995
RECONSTITUTION ACCESSOREIS
K950861
Organon, Inc.
General Hospital · 88d
Cleared May 23, 1995
EXTENTION SET
K933524
Mediziv Medical Products 1987 , Ltd.
General Hospital · 672d
Cleared Mar 24, 1995
IVID
K950200
Scott/Ross Designs, Inc.
General Hospital · 65d
Cleared Mar 16, 1995
SILCLEAR TUBING
K943992
Degania Silicone , Ltd.
General Hospital · 212d
Cleared Mar 09, 1995
VARIOUS TUBING
K943206
Prn Services, Inc.
General Hospital · 247d
Cleared Feb 08, 1995
INTRAVASCULAR ADMINISTRATION SET
K945184
Distronic Sterile Products, Inc.
General Hospital · 107d
Cleared Oct 03, 1994
LIFESHIELD EXTENSION SET
K941214
Abbott Mfg., Inc.
General Hospital · 207d
Cleared Jan 28, 1994
EVANS MEDICAL EXTENSION SETS
K935642
Evans Medical, Inc.
General Hospital · 67d
Cleared Feb 05, 1993
NON-INVASIVE TUBING
K921450
Specialty Medical Sales, Inc.
General Hospital · 316d
Cleared Nov 04, 1992
OPHTHALMIC FLUID DISTRIBUTION SETS
K923972
Visitec Co.
General Hospital · 89d
Cleared May 14, 1992
LO-PROFILE EXTENSION SET
K915560
Douglas Medical Products Corp.
General Hospital · 155d
Cleared Dec 13, 1991
LIFESHIELD EXTENSION SET
K912103
Abbott Laboratories
General Hospital · 214d

About Product Code FPK - Regulatory Context