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 |
|---|---|---|---|
| Jun 14, 1991 | K911136 | B-D SAFETY-LOK(TM) I.V. NEEDLES Bd Becton Dickinson Vacutainer Systems Preanalytic | FPA |
| Jun 4, 1991 | K905219 | 4' LOW VOLUME IV EXTENSION SET Marquette Medical, Inc. | FPA |
| Jun 4, 1991 | K905218 | 4 LOW VOLUME IV EXTENSION SET WITH SLIDE CLAMP Marquette Medical, Inc. | FPA |
| May 31, 1991 | K905374 | IV EXTENSION SETS WITH .22 MICRON FILTER Marquette Medical, Inc. | FPA |
| May 14, 1991 | K910142 | SPARK KIT(R), MODIFICATION Lyphomed, Inc. | FPA |
| Apr 29, 1991 | K910546 | PIGGY LOCK NEEDLE HOUSING Icu Medical, Inc. | FPA |
| Mar 21, 1991 | K910695 | AUTO SASH (TM) Block Medical, Inc. | FPA |
| Jan 11, 1991 | K904886 | VASCULAR ACCESS PORT CONTINUOUS INFUSION SETS Florida Infusion Services, Inc. | FPA |
| Dec 14, 1990 | K902858 | AVI MODEL 4206 MANIFOLD CHECKVALVE IV ADMIN. SET 3M Avi, Inc. | FPA |
| Nov 21, 1990 | K904685 | EXEL HUBER INFUSION SET WITHOUT INJECTION SITE (Y) Exel Intl. | FPA |
| Nov 13, 1990 | K902810 | STERILE I.V. START KIT Orion Life Systems, Inc. | FPA |
| Oct 19, 1990 | K902109 | STATLOCK IV CONNECTOR AND ANCHOR SET Venetec, Inc. | FPA |
| Oct 4, 1990 | K901089 | LOW VOLUME TRIFURCATED IV EXTENSION SET Marquette Medical, Inc. | FPA |
| Oct 4, 1990 | K901088 | LOW VOLUME BIFURCATED IV EXTENSION SET Marquette Medical, Inc. | FPA |
| Oct 4, 1990 | K900336 | V SET Go Medical Industries Pty. , Ltd., AU | FPA |
| Oct 3, 1990 | K904217 | PRO-LOK (TM) EXTENSION SETS Vlv Associates, Inc. | FPA |
| Oct 3, 1990 | K903809 | PROTECTED NEEDLE WITH OR WITHOUT IV SET Kendall Mcgaw Laboratories, Inc. | FPA |
| Oct 1, 1990 | K904013 | SPIVE NEEDLE SYSTEM, MODIFICATION Pascall Medical Corp. | FPA |
| Sep 21, 1990 | K902330 | E-Z FLO + SET Prn Services, Inc. | FPA |
| Sep 14, 1990 | K903541 | SAFETY INJECTION PORT Du-Call Miller Plastics, Inc. | FPA |
| Sep 12, 1990 | K901949 | IV SET Jfv, Inc. | FPA |
| Sep 12, 1990 | K896896 | KAWASUMI SMALL VEIN INFUSION SET Kawasumi Laboratories Co., Ltd. | FPA |
| Sep 12, 1990 | K896895 | KAWASUMI I.V. ADMINISTRATION SET Kawasumi Laboratories Co., Ltd. | FPA |
| Sep 12, 1990 | K896894 | KAWASUMI BLOOD ADMINISTRATION SET Kawasumi Laboratories Co., Ltd. | FPA |
| Sep 12, 1990 | K896893 | KAWASUMI I.V. ADMINISTRATION SET WITH BURETTE Kawasumi Laboratories Co., Ltd. | FPA |
| Sep 12, 1990 | K896892 | KAWASUMI Y-TYPE BLOOD ADMINISTRATION SET Kawasumi Laboratories Co., Ltd. | FPA |
| Aug 17, 1990 | K902166 | WINGED INFUSION SET Therex Corp. | FPA |
| Jul 19, 1990 | K895770 | EXEL HUBER INFUSION SET Exel Intl. | FPA |
| Jul 2, 1990 | K901151 | I.V. ADMINISTRATION SET CONNECTING DEVICE Dmd, Div. of Casta Pacific Co. | FPA |
| Jun 26, 1990 | K902196 | MODIFIED STICK-GARD SAFETY NEEDLE Ziehm International, Inc. | FPA |
| Jun 22, 1990 | K900353 | SHIELDED PIGGYBACK IV NEEDLE Pascall Saringia Medical Corp. | FPA |
| Jun 18, 1990 | K901729 | SAF-T CLIK I.V. IN-LINE CONNECTOR & EXTENSION SET Ryan Medical, Inc. | FPA |
| Jun 8, 1990 | K901081 | PRO-LOCK(TM) SHIELDING NEEDLE CONNECTOR ASSEMBLY Vlv Associates, Inc. | FPA |
| Jun 8, 1990 | K901046 | VERSA-LOCK(TM) UNIVERSAL NEEDLE CONNECTOR Vlv Associates, Inc. | FPA |
| May 18, 1990 | K900909 | IN-LINE VIAL CONNECTION SITE Baxter Healthcare Corp | FPA |
| May 7, 1990 | K900651 | TS-1800 MEDICATION TRANSFER SPIKE The Medi-Dose Group | FPA |
| May 1, 1990 | K900188 | ADVANCE ADMINISTRATION SETS (VARYING LENGTH) Advance Medical Designs, Inc. | FPA |
| May 1, 1990 | K900187 | ADVANCE CONTRAST MEDIA SETS (VARYING LENGTH) Advance Medical Designs, Inc. | FPA |
| Mar 9, 1990 | K900644 | I.V. FREEDOM CLIP Infection Control Products, Inc. | FPA |
| Feb 28, 1990 | K900427 | IV TRIFURCATED EXTENSION SET Marquette Medical, Inc. | FPA |
| Feb 28, 1990 | K900426 | IV BIFURCATED EXTENSION SET Marquette Medical, Inc. | FPA |
| Feb 16, 1990 | K897065 | PORT INFUSION SET (PIS) INFUSION SET (IS) Prn Services, Inc. | FPA |
| Feb 1, 1990 | K896561 | EXTENSION SET Westmark, Sterile Packing Systems, Inc. (Sps) | FPA |
| Jan 18, 1990 | K896346 | GRIPPER PORT-A-CATH NEEDLE WITH STOPCOCK Pharmacia Deltec, Inc. | FPA |
| Jan 11, 1990 | K896161 | AVI MODEL 2012, 1.2 MICRON FILTER IV ADMINISTRA. 3M Company | FPA |
| Dec 27, 1989 | K895291 | IV DISPESNSING SPIKE The Medi-Dose Group | FPA |
| Dec 27, 1989 | K895290 | CHEMO-SPIKE RECONSTITUTION DEVICE The Medi-Dose Group | FPA |
| Dec 6, 1989 | K893646 | VOLUMETRIC PUMP SOLUTION SET W/INTEGRAL AIRWAY Baxter Healthcare Corp | FPA |
| Dec 1, 1989 | K896291 | INJECTION PORT II --- FOR INTERMITTENT INJECTION The Medi-Dose Group | FPA |
| Dec 1, 1989 | K895480 | BLUNT NEEDLE PORT/I.V. PORT Applied Medical Technologies | FPA |
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