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 |
|---|---|---|---|
| Jul 20, 1993 | K924721 | BAXTER SOLUTION ADMINISTRATION SETS Baxter Healthcare Corp | FPA |
| Jul 9, 1993 | K921322 | MORSE ANESTHESIA MANIFOLD Namic | FPA |
| Jun 18, 1993 | K925126 | INTERLINK(TM) INJECTION SITE Baxter Healthcare Corp | FPA |
| Jun 18, 1993 | K924718 | SHROUDED NEEDLE DEVICES Imed Corp. | FPA |
| Jun 17, 1993 | K923560 | ACCU-DROP I.V. EXTENSION SET Lamtic, Inc. | FPA |
| Jun 4, 1993 | K922637 | HORIZON PUMP Y-TYPE BLOOD SET Mcgaw, Inc. | FPA |
| May 26, 1993 | K924207 | AVI(TM) MODEL 232 STANDARD IV ADMINISTRATION SET 3M Health Care, Ltd. | FPA |
| Apr 20, 1993 | K921899 | INTERLINK SYSTEM - T-CONNECTOR EXTENSION SET Baxter Healthcare Corp | FPA |
| Mar 15, 1993 | K922469 | PRO-LOK EXTENSION SET(S) Vlv Associates, Inc. | FPA |
| Dec 24, 1992 | K923882 | IV-TUBE SECURE Ximedix, Inc. | FPA |
| Dec 24, 1992 | K921594 | HAEMOTROL MODEL #HT-SB/6 BURETTE SET Haemotronic, Inc. | FPA |
| Dec 17, 1992 | K921429 | SOLUTION ADMINISTRATION SET Sierra Medical Devices | FPA |
| Nov 23, 1992 | K904663 | AUTO SASH (TM) Block Medical, Inc. | FPA |
| Nov 5, 1992 | K913982 | LIFESHIELD ANESTHESIA SET Abbott Laboratories | FPA |
| Oct 19, 1992 | K922558 | INTERLINK(TM) INJECTION SITE Baxter Healthcare Corp | FPA |
| Oct 13, 1992 | K920537 | SUBCUTANEOUS INFUSION SET Marquette Medical, Inc. | FPA |
| Sep 23, 1992 | K921674 | LIFEPORT INFUSION SET AND INFUSION SET W/ Y SITE Strato Medical Corp. | FPA |
| Sep 21, 1992 | K921576 | STRATO LIFEPORT LARGE BORE INFUSION SET Starto Medical Corp. | FPA |
| Sep 21, 1992 | K915571 | CLAVE CONNECTOR Icu Medical, Inc. | FPA |
| Sep 2, 1992 | K921391 | SOLUTION ADMINISTRATION SET Douglas Medical Products Corp. | FPA |
| Jul 30, 1992 | K921860 | MODIFICATION TO IV SPIKE Mcgaw, Inc. | FPA |
| Jul 30, 1992 | K915678 | MERIT ADMINISTRATION SET Merit Medical Systems, Inc. | FPA |
| Jun 4, 1992 | K921703 | CONTINU-FLO(R) SOLUTION SET Baxter Healthcare Corp | FPA |
| May 15, 1992 | K915828 | INJECTION SITE WITH LUER LOCK Baxter Healthcare Corp | FPA |
| May 8, 1992 | K915109 | RAPID ADD SITE DOUBLE LUMEN I.V.EXTENSION SET Ballard Medical Products | FPA |
| Mar 23, 1992 | K920694 | 8000 SERIES VOLUMETRIC PUMP NON-GRAVITY FLOW SET Baxter Healthcare Corp | FPA |
| Mar 12, 1992 | K915390 | 3 LEAD EXTENSION WITH 2 INTERLINK INJECTION SITES Baxter Healthcare Corp | FPA |
| Mar 6, 1992 | K914924 | CHEMO PRIMING PIN(TM) Block Medical, Inc. | FPA |
| Feb 11, 1992 | K913337 | INJECTION CAP Cp Medical | FPA |
| Jan 22, 1992 | K914113 | ANGIOGRAPHIC FLUSH SYSTEM E-Z-Em, Inc. | FPA |
| Jan 15, 1992 | K914792 | PN 62290 0.22 MICRON MICRO INFUS I.V. EXTEN SET Filtertek, Inc. | FPA |
| Jan 10, 1992 | K905208 | MORSE ANESTHESIA North American Instrument Corp. | FPA |
| Jan 9, 1992 | K914026 | ANGIODYNAMICS ANGIOFILL FLUID MANAGEMENT SYSTEM E-Z-Em, Inc. | FPA |
| Dec 17, 1991 | K912856 | MEDE-FLO I.V. EXTENSION SET Medevice, Inc., CA | FPA |
| Nov 27, 1991 | K914048 | NEEDLE*LOCK(TM) WITH INTERLINK(TM) INJECTION SITE Baxter Healthcare Corp | FPA |
| Oct 23, 1991 | K913333 | I.V. PRIMING SET Gainor Medical Europe, Ltd. | FPA |
| Oct 21, 1991 | K914074 | 8000 SERIES VOLUMETRIC PUMP SOLUTION SET Baxter Healthcare Corp | FPA |
| Oct 17, 1991 | K913076 | I.V. INSTANT TIMER The Master Medical Corp. | FPA |
| Sep 24, 1991 | K912861 | FLU ADMIN/WASTE DISP SYS/PROTEC STA/ADMIN/FLUSH-N- Biocor, Inc. | FPA |
| Sep 23, 1991 | K913627 | 3 PORT ADAPTER Baxter Healthcare Corp | FPA |
| Sep 13, 1991 | K913311 | SAFETY INJECTION PORT, MODIFICATION Riverside Technology, Inc. | FPA |
| Sep 11, 1991 | K912141 | VOLUMETRIC PUMP SOLUTION SET MODIFIED CASSETTE Baxter Healthcare Corp | FPA |
| Sep 6, 1991 | K911128 | MEDIZIV INFUSION SET Medicia Medical Products, IL | FPA |
| Sep 6, 1991 | K910159 | WINGED ADMININ. SET W/NON-CORING NEEDLE Dmd Products | FPA |
| Aug 28, 1991 | K912860 | INTRAVASCULAR ADMINISTRATION SETS Pacific Device, Inc. | FPA |
| Aug 2, 1991 | K911815 | 3RD HAND HELPER Aaron Medical Industries | FPA |
| Jul 26, 1991 | K911443 | INSUL-LINE Trademark Corp. | FPA |
| Jun 24, 1991 | K911868 | INTERLINK(TM) BLUNT CANNULA, MODIFICATION Baxter Healthcare Corp | FPA |
| Jun 24, 1991 | K911753 | INTERVASCULAR ADMINSTRATION SET Mcgaw, Inc. | FPA |
| Jun 18, 1991 | K911931 | LUER LOCK INJECTION CAP Dmd Products | FPA |
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