FPK · Class II · 21 CFR 880.5440

FDA Product Code FPK: Tubing, Fluid Delivery

Leading manufacturers include Churchill Corp., Medrad, Inc. and Medtronic Minimed.

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 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 May 26, 1995
RECONSTITUTION ACCESSOREIS
K950861
Organon, Inc.
General Hospital · 88d
Cleared Nov 04, 1992
OPHTHALMIC FLUID DISTRIBUTION SETS
K923972
Visitec Co.
General Hospital · 89d
Cleared Dec 13, 1991
LIFESHIELD EXTENSION SET
K912103
Abbott Laboratories
General Hospital · 214d
Cleared May 16, 1989
INTRAVASCULAR ADMINISTRATION SET MODEL 60040
K891009
3M Company
General Hospital · 77d
Cleared May 11, 1989
INTRAVASCULAR ADMINI. SET MODELS 60030 & 60050
K891005
3M Company
General Hospital · 72d
Cleared Jan 30, 1989
MERIT HI-FLEX(TM)
K883718
Merit Medical Systems, Inc.
General Hospital · 152d
Cleared Nov 23, 1987
INFUSION MANIFOLD
K873852
Advanced Surgical Products, Inc.
General Hospital · 62d
Cleared Jun 15, 1987
EXTENSION TUBE PUMP SET
K871085
Churchill Corp.
General Hospital · 89d
Cleared Jun 02, 1986
CHURCHILL EXTENSION TUBE
K861626
Churchill Corp.
General Hospital · 41d
Cleared Dec 10, 1985
CHURCHILL-H EXTENSION TUBE
K854629
Churchill Corp.
General Hospital · 22d
Cleared Nov 21, 1983
C-FLEX MEDICAL GRADE TUBING
K833076
Concept, Inc.
General Hospital · 73d
Cleared Feb 05, 1981
SAFEED EXTENSION TUBES
K810005
Terumo Medical Corp.
General Hospital · 30d
Cleared May 14, 1980
EXTENSION SET QUEST CODE #3000
K800825
Quest Medical, Inc.
General Hospital · 30d
Cleared Aug 22, 1977
MONITORING LINES & FLUID ADMIN.
K771387
Norton Performance Plastics Corp.
General Hospital · 26d
Cleared Jun 20, 1977
CONNECTORS
K770596
Abco Dealers, Inc.
General Hospital · 84d

About Product Code FPK - Regulatory Context