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 |
|---|---|---|---|
| Oct 25, 1989 | K895046 | REMOTE RESERVOIR ADAPTER CASSETTE W/BAG SPIKE Pharmacia Deltec, Inc. | FPA |
| Oct 10, 1989 | K895481 | SHAMROCK SAFETY WINGED INFUSION SET Ryan Medical, Inc. | FPA |
| Oct 6, 1989 | K895367 | INTRAVENOUS EXTENSION SET Medical Product Specialists | FPA |
| Sep 27, 1989 | K895109 | SECONDARY IV SET WITH PROTECTED NEEDLE Kendall Mcgaw Laboratories, Inc. | FPA |
| Sep 19, 1989 | K891193 | MEDI-TRACE ACCU-NATE DEVICE Graphic Controls Corp. | FPA |
| Sep 18, 1989 | K893716 | VOLUMETRIC PUMP SOLUTION SET FOR FLO-GARD 8000 Baxter Healthcare Corp | FPA |
| Sep 13, 1989 | K894787 | MEL-PAK GENERAL DRUG DELIVERY SYSTEM KIT New York Blood Center, Inc. | FPA |
| Sep 12, 1989 | K894842 | IMED GEMINI 12 NONVENTED Y-TYPE BLOOD/SOLUTION ADM Imed Corp. | FPA |
| Aug 25, 1989 | K893909 | MODIFIED MATERIAL USED IN INFUSION T Quinton, Inc. | FPA |
| Jul 27, 1989 | K893120 | KIT, INTRAVENOUS EXTENSION TUBING Island Medical | FPA |
| Jul 25, 1989 | K892429 | INJECTION PORT FOR---INTERMITTENT INJECTION The Medi-Dose Group | FPA |
| Jul 24, 1989 | K892440 | KENDALL CURITY EXTENSION TUBES The Kendal Co. | FPA |
| Jul 24, 1989 | K892438 | KENDALL CURITY INTRAVASCULAR CUT DOWN TUBES The Kendal Co. | FPA |
| Jun 23, 1989 | K891164 | SAMUELS - MICRO -SCLER CATHETER Polyval, Inc. | FPA |
| Jun 23, 1989 | K891146 | TERUMO SURFLO(R) INJECTION PLUG Terumo Medical Corp. | FPA |
| Jun 23, 1989 | K891063 | SURFLO(R) WINGED INFUSION SET Terumo Medical Corp. | FPA |
| Jun 8, 1989 | K890489 | EXTENSION SET W/FLOW REGULATOR Baxter Healthcare Corp | FPA |
| May 30, 1989 | K891226 | VASCULAR ACCESS PORT CONTINUOUS INFUSION SET Infucare Products, Inc. | FPA |
| May 18, 1989 | K891176 | INJECTION SITE PLUG (INTRAVASCULAR ADMINISTRATION) Multi-Med, Inc. | FPA |
| May 5, 1989 | K885031 | LOW ADSORPTION ADMINISTRATION SET 3M Company | FPA |
| May 1, 1989 | K890679 | SCALP VEIN SET Ashley Health Care, Inc. | FPA |
| Apr 26, 1989 | K890176 | EXTENSION SETS WITH AND WITHOUT FILTERS Medical Support Systems | FPA |
| Apr 21, 1989 | K891072 | INTRAVASCULAR ADMINISTRATION SET Multi-Med, Inc. | FPA |
| Apr 4, 1989 | K884511 | SAFE MULTIPORT INJECTOR L & W Ent. | FPA |
| Mar 31, 1989 | K890340 | INTRAVASCULAR ADMINISTRATION SET Multi-Med, Inc. | FPA |
| Mar 22, 1989 | K884657 | LILY I.V. SET Modec Co., Inc. | FPA |
| Feb 28, 1989 | K884141 | MONOPLACE HYPERBARIC EXTENSION SET (L 11055) Abbott Laboratories | FPA |
| Feb 24, 1989 | K883986 | CRIS ADAPTER Y | FPA |
| Jan 31, 1989 | K885264 | WINGED INFUSION SET E-Z-Em, Inc. | FPA |
| Jan 31, 1989 | K884102 | MODIFIED 7 INCH CONTINUOUS INFUSION SETS Quinton, Inc. | FPA |
| Jan 24, 1989 | K885030 | STANDARD ADMINISTRATION SETS 3M Company | FPA |
| Dec 19, 1988 | K883764 | INTRAVASCULAR ADMINISTRATION SET Device Labs, Inc. | FPA |
| Nov 14, 1988 | K884264 | HIGH RISK NEEDLE CONNECTOR ASSEMBLY Venture Molded Products, Inc. | FPA |
| Oct 31, 1988 | K884053 | PRN PLUS + INFUSION SET Prn Services, Inc. | FPA |
| Oct 21, 1988 | K883318 | VALLEYLAB I.V. ADMINISTRATION SETS Valleylab, Inc. | FPA |
| Sep 29, 1988 | K883612 | LECTROSPIRAL Vygon Corp. | FPA |
| Sep 23, 1988 | K883638 | SAFESITE INJECTION SITE AND BLUNT CANNULA Baxter Healthcare Corp | FPA |
| Aug 30, 1988 | K882347 | HARMAC EXTENSION INFUSION SET Harmac Medical Specialties, Inc. | FPA |
| Aug 25, 1988 | K882503 | 30 IV EXTENSION SET W/TWO MALE LUER LOCKS Churchill Medical Systems, Inc. | FPA |
| Jul 29, 1988 | K881975 | SET, INTRAVASCULAR Primrose Medical, Inc. | FPA |
| Jul 18, 1988 | K882798 | MULTIFLO ADAPTER Deseret Medical, Inc. | FPA |
| Jul 18, 1988 | K882797 | LUER-LOK MULTIFLO ADAPTER Deseret Medical, Inc. | FPA |
| Jul 12, 1988 | K882302 | IVAC(R) UNVENTED VOL. INFUSION SET MODEL 52080 Y | FPA |
| Jun 20, 1988 | K882007 | EXTENDED LIFE INJECTION SITE Baxter Healthcare Corp | FPA |
| Jun 16, 1988 | K881321 | BLOOD/SOLUTION SET W/PRESSURE PUMP Baxter Healthcare Corp | FPA |
| Jun 13, 1988 | K881234 | VENOVALVE(TM) Abbott Laboratories | FPA |
| May 26, 1988 | K881052 | CHECK VALVE Baxter Healthcare Corp | FPA |
| Apr 29, 1988 | K881390 | NEEDLE SHIELD NEEDLE DISPOSAL UNIT Xenetics Biomedical, Inc. | FPA |
| Apr 29, 1988 | K880928 | MARQUETTE MEDICAL, INC. IV EXTENSION SETS Marquette Medical, Inc. | FPA |
| Apr 1, 1988 | K874725 | SITE SOLUTION ADMINISTRATION SET Site Microsurgical Systems, Inc. | FPA |
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