Panels › General Hospital › Product code FPA · Class 2
Set, Administration, Intravascular
Regulation 880.5440
6510(k)s in 12 months (1,176 all time)
110recalls in 12 months (1,090 all time)
1,030recalls that name a 510(k)
Top companies in FPA
| Company | 510(k)s | Recalls |
|---|---|---|
| B.Braun Medical, Inc. | 23 | 234 |
| Baxter Healthcare Corp | 67 | 151 |
| Icu Medical, Inc. | 27 | 187 |
| Hospira, Inc. | 14 | 109 |
| Smiths Medical MD, Inc. | 4 | 37 |
| Churchill Medical Systems, Inc. | 7 | 32 |
| CME America, LLC | 0 | 38 |
| Abbott Laboratories | 30 | 0 |
| Y | 28 | 0 |
| Carefusion, Inc. | 1 | 25 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 12, 1986 | K861430 | CHURCHILL INJECTION SITE Churchill Corp. | FPA |
| May 6, 1986 | K861439 | CHURCHILL FEMALE LUER LOCK CAP Churchill Corp. | FPA |
| Apr 9, 1986 | K860157 | NITROGLYCERIN INTRAVASCULAR ADMINISTRATION SET Quest Medical, Inc. | FPA |
| Apr 7, 1986 | K860322 | CLINISET INFUSION SET Zimmar Consulting , Ltd., CA | FPA |
| Apr 7, 1986 | K852616 | MIRAGE INTRAVENOUS INFUSION SET OLOVSON-STERILE Medical Hospital Equipment | FPA |
| Mar 25, 1986 | K860541 | SOLUTION ADMINISTRATION SET Travenol Laboratories, S.A. | FPA |
| Mar 24, 1986 | K860605 | FILTER SET 1) 1.2 MIC FILTER 2) 3.0 MIC FILTER Migada, Ltd., IL | FPA |
| Mar 24, 1986 | K854365 | IV SETS WITH NO PHTHALATE PLASTICIZER COMPONENTS Migada, Ltd., IL | FPA |
| Mar 18, 1986 | K860272 | SOLUTION ADMINISTRATION SETS Travenol Laboratories, S.A. | FPA |
| Feb 25, 1986 | K854806 | RAPID SOLUTION ADMIN SET W/INTEGRAL HEAT EXCHANGER Grant Medical Center | FPA |
| Feb 21, 1986 | K854965 | IN LINE VALVE CATALOG NO. 2000A Rao Medical Devices, Inc. | FPA |
| Feb 13, 1986 | K860242 | JMS INFUSION SET Sturbridge Medical | FPA |
| Feb 12, 1986 | K854804 | MULTIPLE I.V. SETS C. B. Dumont Company, Inc. | FPA |
| Feb 4, 1986 | K860201 | PARENTERAL ADMINISTRATION SET Migada, Ltd., IL | FPA |
| Feb 4, 1986 | K854754 | PATIENTMATE TM Trend Medical, Inc. | FPA |
| Jan 27, 1986 | K854658 | CHURCHILL - HBC VENTED BALL CHECK IV SET Churchill Corp. | FPA |
| Jan 23, 1986 | K854574 | IVAC CONTROLLED RELEASE INFUSION SYSTEM Y | FPA |
| Jan 9, 1986 | K854628 | CHURCHILL-HCM VENTED IV SET Churchill Corp. | FPA |
| Jan 9, 1986 | K854446 | TERUMO TERUFUSION BLOOD & Y-TYPE ADMIN. SET Terumo Medical Corp. | FPA |
| Dec 10, 1985 | K854636 | CHURCHILL-HE VENTED IV SET Churchill Corp. | FPA |
| Dec 10, 1985 | K854630 | CHURCHILL-HS SUSPENDED NON-VENTED IV SET Churchill Corp. | FPA |
| Dec 10, 1985 | K854627 | CHURCHILL-HS SUSPENDED VENTED IV SET Churchill Corp. | FPA |
| Dec 5, 1985 | K854437 | CHURCHILL-H VENTED IV SET Churchill Corp. | FPA |
| Dec 5, 1985 | K854436 | CHURCHILL-H SCALP VEIN SET Churchill Corp. | FPA |
| Dec 5, 1985 | K854435 | CHURCHILL-H NON-VENTED IV SET Churchill Corp. | FPA |
| Nov 18, 1985 | K854346 | MEDIFLEX DISPOSABLE TUBING CLAMP Mediflex Intl. | FPA |
| Nov 18, 1985 | K852254 | I.V. STAT MASTER The Master Medical Corp. | FPA |
| Nov 12, 1985 | K853019 | NITROGLYCERIN INFUSION SET Lyphomed, Inc. | FPA |
| Oct 17, 1985 | K853287 | HUBOUT I M, Inc. | FPA |
| Sep 23, 1985 | K853527 | JUFREY CORP. UNIV. DISPOS. SCALP VEIN INFUSION SET Jufrey Multimed Corp. | FPA |
| Sep 19, 1985 | K852606 | FLEBOSET 1401(60 DROPS/MI) AND FLEBOSET1400(20) Infarkem Corp. | FPA |
| Sep 5, 1985 | K853204 | CHURCHILL VENTED IV SET Churchill Corp. | FPA |
| Aug 23, 1985 | K853385 | I.A.S.S., IV SET W/AIR VENT & I.A.P.S. W/O AIRVENT Migada, Ltd., IL | FPA |
| Aug 23, 1985 | K853255 | OMNIMED I.V. SOLUTION ADMIN. SET Omni Intl., Inc. | FPA |
| Aug 23, 1985 | K851516 | CHERMEL SCALP VEIN SET Cher Mel Corp. | FPA |
| Aug 22, 1985 | K853387 | ET - EXTENSION SETS Migada, Ltd., IL | FPA |
| Aug 21, 1985 | K853327 | JUFREY CORP. UNIVERSAL DISPOS. SCALP VEIN INFUSION Jufrey Multimed Corp. | FPA |
| Aug 19, 1985 | K853086 | SECONDARY ADMINISTRATION SET Lyphomed, Inc. | FPA |
| Aug 16, 1985 | K852881 | VENTED SECONDARY IV ADMINISTRATION SET Lyphomed, Inc. | FPA |
| Aug 13, 1985 | K853184 | PIGGYMATE I.V. TUBING LOCK Trend Medical, Inc. | FPA |
| Jul 26, 1985 | K852989 | WINGED INFUSION SETS An-Med Intl. | FPA |
| Jul 16, 1985 | K852361 | INTRAVENOUS INJECTION SET The West Co., Inc. | FPA |
| Jun 27, 1985 | K852488 | CONTROLLED RELEASE INFUSION SYSTEM(CRIS) Y | FPA |
| Jun 7, 1985 | K852259 | IVENT INTRAVENOUS ADMINSTRATION SET Ivent Corp. | FPA |
| Jun 7, 1985 | K852106 | I.V. ADMINISTRATION SET Mediflex Intl. | FPA |
| May 30, 1985 | K852140 | NAMIC CONTRAST & FLUID DELIVERY SPIKES(VARIOUS) North American Instrument Corp. | FPA |
| May 30, 1985 | K851336 | IV/0165 INFUSION SET Infarkem Corp. | FPA |
| May 29, 1985 | K850769 | VIGGO ACCESSORIES FOR I.V. THERAPY Viggo Products | FPA |
| May 7, 1985 | K851299 | CORRECT FLO Norton Performance Plastics Corp. | FPA |
| Apr 12, 1985 | K850277 | VIGGO I.V. ACCESSORIES-VIGGO EXTENSION TUBES ETC. Viggo Products | FPA |
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