Product code FPK
- Device name
- Tubing, Fluid Delivery
- Medical specialty
- General Hospital
- Device class
- 2
- Regulation number
- 880.5440
- Review panel
- HO
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K131517 | MEDRAD TWIST & GO HIGH PRESSURE CONNECTOR TUBING | Medrad, Inc. / Bayer Medical Care, Inc. | 2013-08-02 |
| K063114 | DISPOSABLE TRANSFER SETS WITH AND WITHOUT SWABBABLE VALVES AND/OR CHECK VALVES | Coeur, Inc. | 2007-02-09 |
| K063239 | LIFESHIELD LATEX-FREE GRAVITECH FLOW CONTROLLER I.V. SETS, MODELS 17528, 17527, 17525 & 17526 | Hospira, Inc. | 2006-12-11 |
| K052431 | MEDTRONIC MINIMED LEAPFROG II INFUSION SET, MODELS MMT-801S1, MMT-801L1, MMT-801S2, MMT-801L2, MMT-803S1 | Medtronic Minimed | 2005-11-29 |
| K041178 | EMPOWER TRANSFER SET, (CAT. NO. 7725) | E-Z-Em, Inc. | 2004-07-16 |
| K031808 | MEDRAD SWABBABLE VALVE TRANSFER SET | Medrad, Inc. | 2003-07-11 |
| K022431 | MEDRAD TRANSFER SET | Medrad, Inc. | 2002-09-05 |
| K965208 | POLYFIN EXTENSION SET, MODELS 126 AND 128 | Medtronic Minimed | 1997-02-26 |
| K953864 | SILCLEAR TUBING (MODIFICATION) | Degania Silicone , Ltd. | 1995-11-06 |
| K950508 | SYSMEX SF-3000 | Sysmex Corp. | 1995-11-03 |
| K952243 | EXTENSION SET/I.V. SET | Coast Medical, Inc. | 1995-07-26 |
| K952663 | 60 MICRO VOLUME EXTENSION SET W/.22 MICRON FILTER, 21 EXTENSION SET W/1.2 MIVTON GILYRT, INJ. SITE, CLAMP | Distronic Sterile Products, Inc. | 1995-07-14 |
| K950861 | RECONSTITUTION ACCESSOREIS | Organon, Inc. | 1995-05-26 |
| K933524 | EXTENTION SET | Mediziv Medical Products 1987 , Ltd. | 1995-05-23 |
| K950200 | IVID | Scott/Ross Designs, Inc. | 1995-03-24 |
| K943992 | SILCLEAR TUBING | Degania Silicone , Ltd. | 1995-03-16 |
| K943206 | VARIOUS TUBING | Prn Services, Inc. | 1995-03-09 |
| K945184 | INTRAVASCULAR ADMINISTRATION SET | Distronic Sterile Products, Inc. | 1995-02-08 |
| K941214 | LIFESHIELD EXTENSION SET | Abbott Mfg., Inc. | 1994-10-03 |
| K935642 | EVANS MEDICAL EXTENSION SETS | Evans Medical, Inc. | 1994-01-28 |
| K921450 | NON-INVASIVE TUBING | Specialty Medical Sales, Inc. | 1993-02-05 |
| K923972 | OPHTHALMIC FLUID DISTRIBUTION SETS | Visitec Co. | 1992-11-04 |
| K915560 | LO-PROFILE EXTENSION SET | Douglas Medical Products Corp. | 1992-05-14 |
| K912103 | LIFESHIELD EXTENSION SET | Abbott Laboratories | 1991-12-13 |
| K910906 | CENTURION KLEEN-NEEDLE SYSTEM I.V. EXTENSION SETS | Tri-State Hospital Supply Corp. | 1991-04-01 |
| K891009 | INTRAVASCULAR ADMINISTRATION SET MODEL 60040 | 3M Company | 1989-05-16 |
| K891005 | INTRAVASCULAR ADMINI. SET MODELS 60030 & 60050 | 3M Company | 1989-05-11 |
| K883718 | MERIT HI-FLEX(TM) | Merit Medical Systems, Inc. | 1989-01-30 |
| K884156 | HYPERBARIC INTRAVENOUS INFUSION EXTENSION SET | Sechrist Industries, Inc. | 1988-11-14 |
| K884370 | CMS IV EXTENSION SETS | Churchill Medical Systems, Inc. | 1988-11-07 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08426314583527 | FLEBOSET | LABORATORIOS GRIFOLS SA | 2017-04-05 |
| 08498840004999 | VYGON | Vygon Corporation | 2016-09-19 |
| 08498840004722 | VYGON | Vygon Corporation | 2016-08-09 |
| 08498840002278 | VYGON | Vygon Corporation | 2016-08-09 |
| 08498840007327 | VYGON | Vygon Corporation | 2016-08-05 |
| 08498840007310 | VYGON | Vygon Corporation | 2016-08-05 |
| 08498840006719 | VYGON | Vygon Corporation | 2016-08-05 |
| 08498840006559 | VYGON | Vygon Corporation | 2016-08-05 |
| 08498840006443 | VYGON | Vygon Corporation | 2016-08-05 |
| 08498840001677 | VYGON | Vygon Corporation | 2016-08-05 |
| 08498840001660 | VYGON | Vygon Corporation | 2016-08-05 |
| 08498840001523 | VYGON | Vygon Corporation | 2016-08-05 |
| 08498840001486 | VYGON | Vygon Corporation | 2016-08-05 |
| 08498840001424 | VYGON | Vygon Corporation | 2016-08-05 |
| 08498840001301 | VYGON | Vygon Corporation | 2016-08-05 |
| 08498840001219 | VYGON | Vygon Corporation | 2016-08-04 |
| 08498840001202 | VYGON | Vygon Corporation | 2016-08-04 |
| 08498840001196 | VYGON | Vygon Corporation | 2016-08-04 |
| 08498840001110 | VYGON | Vygon Corporation | 2016-08-04 |
| 08498840001035 | VYGON | Vygon Corporation | 2016-08-04 |
| 08498840001028 | VYGON | Vygon Corporation | 2016-08-04 |
| 08498840000991 | VYGON | Vygon Corporation | 2016-08-04 |
| 08498840000960 | VYGON | Vygon Corporation | 2016-08-03 |
| 08498840000953 | VYGON | Vygon Corporation | 2016-08-03 |
| 08498840000908 | VYGON | Vygon Corporation | 2016-08-03 |
| 08498840000885 | VYGON | Vygon Corporation | 2016-08-03 |
| 08498840000823 | VYGON | Vygon Corporation | 2016-08-03 |
| 08498840000809 | VYGON | Vygon Corporation | 2016-08-01 |
| 08498840000762 | VYGON | Vygon Corporation | 2016-08-01 |
| 08498840000700 | VYGON | Vygon Corporation | 2016-08-01 |