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 |
|---|---|---|---|
| Apr 9, 1985 | K844843 | IVAC DRUG ADMINISTRATION DEVICE Y | FPA |
| Apr 1, 1985 | K850506 | CORRECT FLO INTRAVASCULAR ADMINISTRATION SET Biomedical Dynamics, Inc. | FPA |
| Mar 27, 1985 | K850061 | MICRO VOLUME DOUBLE LINE EXTENSION SET Travenol Laboratories, S.A. | FPA |
| Mar 21, 1985 | K850533 | ATLANTIC OPTICAL SYSTEMS OPTIFILTER SYSTEM Atlantic Optical Systems, Inc. | FPA |
| Mar 12, 1985 | K850339 | SPECIAL PROCEDURES PACK Marwood Medical, Inc. | FPA |
| Mar 7, 1985 | K850507 | CRITIKON I.V. ADMINISTRAION SET Critikon Company, LLC | FPA |
| Feb 22, 1985 | K850112 | OMNIMED IV SOLUTION ADMINISTRATION SET Omni Intl., Inc. | FPA |
| Feb 7, 1985 | K844917 | TURN NEEDLE INTRAVENOUS CANNUL, NUB, W/TUBING INTE Turn Needle Intl., Inc. | FPA |
| Feb 2, 1985 | K850088 | ARTERIAL EXTENSION SET Medical Matrix, Inc. | FPA |
| Jan 28, 1985 | K844820 | FLOW MED SK 140 BURET D.R.O. Medical, Inc. | FPA |
| Jan 25, 1985 | K844937 | IVAC 52-99-0 UNVENTED & 52-99-1 VENTED VOL. INFUSI Y | FPA |
| Jan 3, 1985 | K843748 | ANTI-ASPIRATION VALVE Travenol Laboratories, S.A. | FPA |
| Dec 19, 1984 | K844255 | GENT-L-KARE STERILE I.V. START KIT Geneva Laboratories, Inc. | FPA |
| Dec 4, 1984 | K843090 | UNIVERSITY OF CHICAGO VASCULAR ANGIOGRAM Geneva Laboratories, Inc. | FPA |
| Oct 31, 1984 | K843692 | FLU VEN I.V. SET 0153-C PERMA-SET Venusa , Ltd. | FPA |
| Oct 19, 1984 | K843631 | MINISET VEIN INFUSION SETS Travenol Laboratories, S.A. | FPA |
| Oct 16, 1984 | K842984 | EXTENSION SET W/INJECTION SITE Med Fusion Systems, Inc. | FPA |
| Oct 15, 1984 | K842351 | STERILE DESIGN-CUSTOM STERILE IV KIT Sterile Design, Inc. | FPA |
| Oct 11, 1984 | K843463 | PROVIDER BAG SPIKE W/12 MICROBORE EXTEN Pancretec, Inc. | FPA |
| Oct 9, 1984 | K842678 | I.V. TRANSFER SPIKE Lyphomed, Inc. | FPA |
| Sep 20, 1984 | K843185 | IVAC C80014 Y SOLUTION ADMIN. SET Y | FPA |
| Sep 13, 1984 | K843054 | DEKA SOLUTION ADMIN. SET DK 302-A Deka Research & Development Corp. | FPA |
| Sep 11, 1984 | K842858 | FLUID ADMINISTRATION LINE W/SPIKE 14-923 Norton Performance Plastics Corp. | FPA |
| Sep 7, 1984 | K843249 | T-TYPE IV EXTENSION SET Strato Medical Corp. | FPA |
| Aug 17, 1984 | K842657 | ACCESS. TO INTERAVACULAR ADMIN. SET Tanner Corp. | FPA |
| Aug 17, 1984 | K842088 | FLU MET 2 Venusa , Ltd. | FPA |
| Aug 7, 1984 | K842985 | T- EXTENSION SET T-04-C Tico Medical Instruments, Inc. | FPA |
| Jul 23, 1984 | K841717 | INTRAVENOUS INJECTION SET Philadelphia Biologics Center | FPA |
| Jul 23, 1984 | K841562 | HESUNG BLOOD TRANSFUSION SETS Amkor Trading Co. | FPA |
| Jul 20, 1984 | K842143 | BENT WINGED MINI-VOL INFUSION SET Med Fusion Systems, Inc. | FPA |
| Jul 17, 1984 | K841564 | HESUNG SCALP VEIN SET Amkor Trading Co. | FPA |
| Jul 17, 1984 | K841563 | HESUNG'S SOLUTION INFUSION SETS Amkor Trading Co. | FPA |
| Jul 6, 1984 | K841772 | HEPARIN CAP, INJECTION CAP MALE LUER- Linton Biomed Corp. | FPA |
| Jul 3, 1984 | K841859 | SECURA SET Diatek, Inc. | FPA |
| Jun 5, 1984 | K841882 | THREE WAY INFUSION SET Med Fusion Systems, Inc. | FPA |
| May 21, 1984 | K841361 | SYRINGE ADDITIVE IV ADMIN. SETS Quest Medical, Inc. | FPA |
| May 21, 1984 | K841186 | INFUSION SET SCALP VEIN Marbex, Inc. | FPA |
| May 21, 1984 | K841185 | PLASTIC, STERILE TUBING CLOSED SET Marbex, Inc. | FPA |
| May 14, 1984 | K841106 | DELTA MULTIPLE NON RETURN CONNECTOR Tefra Med, Inc. | FPA |
| Apr 17, 1984 | K840443 | RETROGRADE INFUSION SET 3ML & 6ML- Tico Medical Instruments, Inc. | FPA |
| Apr 16, 1984 | K841027 | PROVIDER SITE PREP & CHECK STRIP KIT Pancretec, Inc. | FPA |
| Apr 5, 1984 | K841028 | PROVIDER CAP SET Pancretec, Inc. | FPA |
| Apr 5, 1984 | K840760 | HARVARD ANTI-REFLUX Y-SET C.R. Bard, Inc. | FPA |
| Mar 30, 1984 | K841025 | TOP DISPOSABLE INFUSION SET Top Surgical Manufacturers Co. | FPA |
| Mar 30, 1984 | K840878 | QUIK LOK Abbott Laboratories | FPA |
| Mar 27, 1984 | K840619 | I.V. START KIT Marwood Medical, Inc. | FPA |
| Mar 19, 1984 | K840410 | SOLUTION ADMIN. SET STERILE Loversan | FPA |
| Mar 19, 1984 | K840409 | INFUSION SET-STERILE Loversan | FPA |
| Mar 6, 1984 | K840273 | LOPEZ LOCK Icu Medical, Inc. | FPA |
| Mar 6, 1984 | K840212 | CONCENTRATED PLATELET ADMIN. SET American Mcgaw | FPA |
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