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 |
|---|---|---|---|
| Mar 18, 1988 | K880482 | SECONDARY SOLUTION ADMINISTRATION SET W/SHEATH Baxter Healthcare Corp | FPA |
| Jan 29, 1988 | K874307 | MODEL DMC-75 MINI-CATHETER SET Life-Tech Intl., Inc. | FPA |
| Jan 19, 1988 | K874581 | IVAC(R) DUAL RATE ADAPTER - MODEL 70090 Y | FPA |
| Jan 14, 1988 | K874133 | MX710 SERIES VASCULAR ACCESS INFUSION SET Medex, Inc. | FPA |
| Jan 6, 1988 | K874467 | SET, ADMINISTRATION INTRAVASCULAR Kendall Mcgaw Laboratories, Inc. | FPA |
| Jan 6, 1988 | K872953 | DISPOSABLE I.V. ADMINISTRATION SET Mac Lee Medical Products | FPA |
| Dec 29, 1987 | K874403 | A SERIES OF 7 INCH CONTINUOUS INFUSION SETS Quinton, Inc. | FPA |
| Dec 29, 1987 | K873729 | RATE-MATE NITROGLYCERIN I.V. ADMINISTRATION SET Critikon Company, LLC | FPA |
| Nov 5, 1987 | K873894 | CONTINU-FLO SOLUTION W/CHECK VALVE 2 Y-INJECT SITE Travenol Laboratories, S.A. | FPA |
| Nov 3, 1987 | K873885 | PHARMACIA DELTEC SUBCUTANEOUS INFUSION SET Pharmacia Deltec, Inc. | FPA |
| Oct 23, 1987 | K873876 | PHARMACIA DELTEC BAG SPIKE SET Pharmacia Deltec, Inc. | FPA |
| Oct 23, 1987 | K873042 | MODEL 1330 EXTENSION SET Pharmacia Deltec, Inc. | FPA |
| Oct 23, 1987 | K871995 | MICROS(TM) Controlled Release Technologies, Inc. | FPA |
| Oct 22, 1987 | K872945 | LOOK FLUID DISTRIBUTION SET Look, Inc. | FPA |
| Oct 13, 1987 | K872124 | CHURCHILL ALBUMIN IV ADMINISTRATION SET Churchill Corp. | FPA |
| Oct 9, 1987 | K872123 | CHURCHILL TPN ADMINISTRATION SET Churchill Corp. | FPA |
| Sep 4, 1987 | K872795 | CHANGE IN STERILITY TEST METHOD & TEST LAB. SITE Medex, Inc. | FPA |
| Jul 31, 1987 | K870995 | SCALP VEIN SET Mac Lee Medical Products | FPA |
| Jul 21, 1987 | K871843 | TWO FLUID W/CHECK VALVE Panamedix, Inc. | FPA |
| Jun 25, 1987 | K870866 | THE GRIPPER(TM) PORT-A-CATH NEEDLES Pharmacia, Inc. | FPA |
| Jun 24, 1987 | K871842 | TWO FLUID I.V. SETS Panamedix, Inc. | FPA |
| Jun 24, 1987 | K871841 | THREE FLUID I.V. SETS Panamedix, Inc. | FPA |
| Jun 15, 1987 | K871732 | CHURCHILL-H VENTED IV SET W/METERING CHAMBERS Churchill Corp. | FPA |
| Jun 15, 1987 | K871086 | IV PUMP SET Churchill Corp. | FPA |
| Jun 5, 1987 | K871753 | MASTER MEDICAL DEVICE IS I.V. STAT 2 The Master Medical Corp. | FPA |
| Apr 23, 1987 | K870582 | LIFEPORT(R) 7 INCH CONTINUOUS INFUSION W/Y-SITE Strato Medical Corp. | FPA |
| Apr 23, 1987 | K870581 | LIFEPORT(R) 7 INCH CONTINUOUS INFUSION SET Strato Medical Corp. | FPA |
| Mar 17, 1987 | K870940 | SOLUTION ADMINI. SETS- ALTER. DRIP CHAMBER/CONNEC. Travenol Laboratories, S.A. | FPA |
| Mar 17, 1987 | K870913 | INJECTION SITE #014456-120 Clinical Connections, Inc. | FPA |
| Mar 2, 1987 | K864296 | S.C.T. MULTI PORT, INJECTION SITE Salt Creek Medical Technologies | FPA |
| Feb 10, 1987 | K870188 | NORFOLK MEDICAL BUTTERFLY INFUSION SET Norfolk Medical Products, Inc. | FPA |
| Jan 20, 1987 | K864453 | EMERGENCY & MILITARY INFUSION SYSTEM Migada, Ltd., IL | FPA |
| Dec 18, 1986 | K864405 | MANAN CONTRAST MEDIA ADMINISTRATION SET Manan Manufacturing Co., Inc. | FPA |
| Dec 16, 1986 | K864164 | CRIS ADAPTED WITH VOLUME LIMITING BAG Y | FPA |
| Dec 9, 1986 | K863304 | PRESELECTED FLOW RATE I.V. SET Migada, Ltd., IL | FPA |
| Nov 19, 1986 | K864338 | SECONDARY SET LOCK Travenol Laboratories, S.A. | FPA |
| Oct 14, 1986 | K863814 | BAG SPIKE EXTENSION SET Med Fusion Systems, Inc. | FPA |
| Sep 23, 1986 | K862289 | KOREAN GREEN CROSS SCALP VEIN SET Sturbridge Medical | FPA |
| Aug 27, 1986 | K862491 | EXEL BUTTERFLY SCALP VEIN SET Exel Intl. | FPA |
| Aug 27, 1986 | K860952 | I.V. SET WITH AND WITHOUT AIR VENT Migada, Ltd., IL | FPA |
| Jul 31, 1986 | K862653 | LUER LOCK ADAPTER/NUT Mallinckrodt Critical Care | FPA |
| Jun 4, 1986 | K861182 | TIMELINE VENIPUNCTURE SYSTEM Ipax, Inc. | FPA |
| Jun 4, 1986 | K860609 | TIMELINE VENIPUNCTURE SYSTEM Ipax, Inc. | FPA |
| Jun 2, 1986 | K861275 | HIGH FLOW I.V. SET Migada, Ltd., IL | FPA |
| Jun 2, 1986 | K860616 | VOLUME CONTROL SET WITH EXTENSION Med Fusion Systems, Inc. | FPA |
| May 27, 1986 | K861521 | UNIVERSAL DISPOSABLE INFUSION SET (CODE 0330) Jufrey Multimed Corp. | FPA |
| May 27, 1986 | K861520 | UNIVERSAL DISPOSABLE INFUSION SET (CODE 0205) Jufrey Multimed Corp. | FPA |
| May 27, 1986 | K861519 | UNIVERSAL DISPOSABLE INFUSION SET (CODE 0330F) Jufrey Multimed Corp. | FPA |
| May 27, 1986 | K861518 | UNIVERSAL DISPOSABLE INFUSION SET (CODE 0205F) Jufrey Multimed Corp. | FPA |
| May 23, 1986 | K861250 | MESULIN, INSULIN INFUSION SET Molnlycke A/S Hospital Products, DK | FPA |
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