Panels › General Hospital › Product code FPK · Class 2
Tubing, Fluid Delivery
Regulation 880.5440
0510(k)s in 12 months (64 all time)
0recalls in 12 months (28 all time)
18recalls that name a 510(k)
Top companies in FPK
| Company | 510(k)s | Recalls |
|---|---|---|
| MOOG Medical Devices Group | 0 | 14 |
| Mentor Texas, Inc | 0 | 9 |
| Churchill Corp. | 3 | 0 |
| Clinical Connections, Inc. | 3 | 0 |
| 3M Company | 2 | 0 |
| Degania Silicone , Ltd. | 2 | 0 |
| Distronic Sterile Products, Inc. | 2 | 0 |
| Harvard Laboratories | 2 | 0 |
| Hospira, Inc. | 1 | 1 |
| Medrad, Inc. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 2, 2013 | K131517 | MEDRAD TWIST & GO HIGH PRESSURE CONNECTOR TUBING Medrad, Inc. / Bayer Medical Care, Inc. | FPK |
| Feb 9, 2007 | K063114 | DISPOSABLE TRANSFER SETS WITH AND WITHOUT SWABBABLE VALVES AND/OR CHECK VALVES Coeur, Inc. | FPK |
| Dec 11, 2006 | K063239 | LIFESHIELD LATEX-FREE GRAVITECH FLOW CONTROLLER I.V. SETS, MODELS 17528, 17527, 17525 & 17526 Hospira, Inc. | FPK |
| Nov 29, 2005 | K052431 | MEDTRONIC MINIMED LEAPFROG II INFUSION SET, MODELS MMT-801S1, MMT-801L1, MMT-801S2, MMT-801L2, MMT-803S1 Medtronic Minimed | FPK |
| Jul 16, 2004 | K041178 | EMPOWER TRANSFER SET, (CAT. NO. 7725) E-Z-Em, Inc. | FPK |
| Jul 11, 2003 | K031808 | MEDRAD SWABBABLE VALVE TRANSFER SET Medrad, Inc. | FPK |
| Sep 5, 2002 | K022431 | MEDRAD TRANSFER SET Medrad, Inc. | FPK |
| Feb 26, 1997 | K965208 | POLYFIN EXTENSION SET, MODELS 126 AND 128 Medtronic Minimed | FPK |
| Nov 6, 1995 | K953864 | SILCLEAR TUBING (MODIFICATION) Degania Silicone , Ltd., IL | FPK |
| Nov 3, 1995 | K950508 | SYSMEX SF-3000 Sysmex Corp. | FPK |
| Jul 26, 1995 | K952243 | EXTENSION SET/I.V. SET Coast Medical, Inc. | FPK |
| Jul 14, 1995 | 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. | FPK |
| May 26, 1995 | K950861 | RECONSTITUTION ACCESSOREIS Organon, Inc. | FPK |
| May 23, 1995 | K933524 | EXTENTION SET Mediziv Medical Products 1987 , Ltd., IL | FPK |
| Mar 24, 1995 | K950200 | IVID Scott/Ross Designs, Inc. | FPK |
| Mar 16, 1995 | K943992 | SILCLEAR TUBING Degania Silicone , Ltd., IL | FPK |
| Mar 9, 1995 | K943206 | VARIOUS TUBING Prn Services, Inc. | FPK |
| Feb 8, 1995 | K945184 | INTRAVASCULAR ADMINISTRATION SET Distronic Sterile Products, Inc. | FPK |
| Oct 3, 1994 | K941214 | LIFESHIELD EXTENSION SET Abbott Mfg., Inc. | FPK |
| Jan 28, 1994 | K935642 | EVANS MEDICAL EXTENSION SETS Evans Medical, Inc. | FPK |
| Feb 5, 1993 | K921450 | NON-INVASIVE TUBING Specialty Medical Sales, Inc. | FPK |
| Nov 4, 1992 | K923972 | OPHTHALMIC FLUID DISTRIBUTION SETS Visitec Co. | FPK |
| May 14, 1992 | K915560 | LO-PROFILE EXTENSION SET Douglas Medical Products Corp. | FPK |
| Dec 13, 1991 | K912103 | LIFESHIELD EXTENSION SET Abbott Laboratories | FPK |
| Apr 1, 1991 | K910906 | CENTURION KLEEN-NEEDLE SYSTEM I.V. EXTENSION SETS Tri-State Hospital Supply Corp. | FPK |
| May 16, 1989 | K891009 | INTRAVASCULAR ADMINISTRATION SET MODEL 60040 3M Company | FPK |
| May 11, 1989 | K891005 | INTRAVASCULAR ADMINI. SET MODELS 60030 & 60050 3M Company | FPK |
| Jan 30, 1989 | K883718 | MERIT HI-FLEX(TM) Merit Medical Systems, Inc. | FPK |
| Nov 14, 1988 | K884156 | HYPERBARIC INTRAVENOUS INFUSION EXTENSION SET Sechrist Industries, Inc. | FPK |
| Nov 7, 1988 | K884370 | CMS IV EXTENSION SETS Churchill Medical Systems, Inc. | FPK |
| Feb 16, 1988 | K875186 | IV EXTENSION SET Marquette Medical, Inc. | FPK |
| Jan 20, 1988 | K873465 | VAN DELLEN BACTERIA FILTER Van Dellen, Ltd. | FPK |
| Nov 23, 1987 | K873852 | INFUSION MANIFOLD Advanced Surgical Products, Inc. | FPK |
| Nov 17, 1987 | K874360 | PLASTIC TUBING CONNECTOR American Medical Technology, Inc. | FPK |
| Jun 15, 1987 | K871085 | EXTENSION TUBE PUMP SET Churchill Corp. | FPK |
| Apr 30, 1987 | K871540 | SWIVEL CONNECTORS #014452/#014453/#014459-120 Clinical Connections, Inc. | FPK |
| Apr 6, 1987 | K870416 | LP EXTENSION SETS North Coast Medi-Tek | FPK |
| Mar 17, 1987 | K870912 | T-CONNECTORS 014500/014501/014502/014503-120 Clinical Connections, Inc. | FPK |
| Feb 10, 1987 | K870326 | VARIOUS LUER AND TUBING FITTINGS Clinical Connections, Inc. | FPK |
| Dec 18, 1986 | K864692 | EXTENSION SETS Salt Creek Medical Technologies | FPK |
| Dec 16, 1986 | K864395 | LOW VOLUME EXTENSION SET Panamedix, Inc. | FPK |
| Jun 2, 1986 | K861626 | CHURCHILL EXTENSION TUBE Churchill Corp. | FPK |
| Dec 10, 1985 | K854629 | CHURCHILL-H EXTENSION TUBE Churchill Corp. | FPK |
| Dec 13, 1983 | K834164 | SPINAL NEEDLES & ACCESSORY Elfa Trading Co. | FPK |
| Nov 29, 1983 | K833659 | IV EXTENSION SET Dna Medical, Inc. | FPK |
| Nov 21, 1983 | K833076 | C-FLEX MEDICAL GRADE TUBING Concept, Inc. | FPK |
| Sep 12, 1983 | K832758 | RED COLOR-TINTED TUBING Custom Medical, Inc. | FPK |
| Mar 18, 1982 | K820527 | ANESTHESIA EXTENSION TUBES David Simmonds Co., Inc. | FPK |
| Nov 6, 1981 | K812981 | FLUVEN SETS (EXT-1, EXT-2, EXT-3, EXT-4) Venusa , Ltd. | FPK |
| Jul 13, 1981 | K811847 | SEA MEDICAL PRODUCTS LO-VOL Sea Medical Products, Inc. | FPK |
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