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 |
|---|---|---|---|
| May 21, 1998 | K974571 | SOLUTION ADMINISTRATION SET WITH CAPPED LUER ACTIVATED VALVE Baxter Healthcare Corp | FPA |
| Apr 27, 1998 | K980583 | EXTENSION SET WITH 0.2U FILTER AND ANTI-SIPHON VALVE CADD ADMINISTRATION SET WITH 0.2U FILTER AND ANTI-SIPHON VALVE Sims Deltec, Inc. | FPA |
| Apr 22, 1998 | K981318 | DUAL LUER LOCK CAP Baxter Healthcare Corp | FPA |
| Mar 11, 1998 | K980127 | 6 INCH MINI-BONE EXTENSION SET WITH LUER LOCK, NES01S, 6 INCH MIN-BONE EXTENSION SET WITH LUER SLIP, NES02S, 6 INCH STAT Catheter Innovations, Inc. | FPA |
| Mar 9, 1998 | K973916 | NP MEDICAL CAPLESS LUER ACTIVATED VALVE Np Medical, Inc. | FPA |
| Feb 2, 1998 | K974163 | MINIMED SOF-SET ULTIMATE QR INFUSION SET MODELS 315 AND 316 Medtronic Minimed | FPA |
| Jan 23, 1998 | K971844 | MCKINLEY OUTBOUND-2 SYSTEM Mckinley, Inc. | FPA |
| Jan 9, 1998 | K974589 | SMARTVALVE Icu Medical, Inc. | FPA |
| Jan 6, 1998 | K974145 | V3 VALVE B.Braun Medical, Inc. | FPA |
| Dec 17, 1997 | K974013 | EXTENSION SET WITH MICROBORE TUBING, EXTENSION SET WITH MICROBORE TUBING AND 0.2 U FILTER, EXTENSION SET WITH MICROBORE Sims Deltec, Inc. | FPA |
| Dec 17, 1997 | K972854 | PROTOS I.V. ADMINISTRATION SET (15 DROPS/ML) I4070S/(60 DROPS/ML)I4670S PRELIMINARY Globe Ent., Inc. | FPA |
| Dec 17, 1997 | K972839 | PROTOS 100ML BURETTE INFUSION SET/ PROTOS 150ML BURETTE INFUSION SET Globe Ent., Inc. | FPA |
| Dec 16, 1997 | K963659 | EXEL I.V. ADMINISTRATION SET Exel Intl. | FPA |
| Nov 17, 1997 | K973167 | POSITIVE PRESSURE CONNECTOR Icu Medical, Inc. | FPA |
| Oct 2, 1997 | K973107 | AMSINO I.V. ADMINISTRATION SET Amsino Intl., Inc. | FPA |
| Oct 2, 1997 | K971004 | MEDCORP FLOW I.V. REGULATOR EXTENSION SET Medcorp Intl. | FPA |
| Oct 1, 1997 | K972712 | CORE RESISTANT HUBER INFUSION SETS Icu Medical, Inc. | FPA |
| Sep 29, 1997 | K972957 | SA-EF MULTI-LUMEN EXTENSION SET Vlv Associates, Inc. | FPA |
| Sep 18, 1997 | K972527 | PHASEAL, SYSTEM FOR SEALED HANDLING OF CHEMOTHERAPEUTIC AGENTS Quality System Consulting | FPA |
| Sep 18, 1997 | K972493 | NIPRO DISPOSABLE SOLUTION INFUSION SET Nipro Medical Corp. | FPA |
| Sep 8, 1997 | K971624 | DYE STOP AND SAVE - QUICKFILL Shepherd Laboratories, Inc. | FPA |
| Sep 2, 1997 | K972663 | SMART SET Top Spins, Inc. | FPA |
| Aug 26, 1997 | K972135 | MAERSK MEDICAL PURELINE COMFORT SUBCUTANEOUS INFUSION SET P/L Biomedical | FPA |
| Aug 18, 1997 | K971500 | ACCESS SYSTEMS NEEDLELESS VIAL ADAPTER Biological & Environmental Control Laboratories | FPA |
| Jul 16, 1997 | K964439 | NEEDLE-FREE VALVED CONNECTOR AND CAP Bmw Medical, Inc. | FPA |
| Jun 27, 1997 | K971293 | LIFESHIELD PRIMARY I.V. SET WITH BACKCHECK VALVE Abbott Mfg., Inc. | FPA |
| Jun 24, 1997 | K970855 | CLAVE CONNECTOR Icu Medical, Inc. | FPA |
| Jun 24, 1997 | K965027 | VENTED I.V. SET Jms Co., Ltd., JP | FPA |
| Jun 6, 1997 | K971701 | CONTINU-FLO SOLUTION SET Baxter Healthcare Corp | FPA |
| Jun 5, 1997 | K964067 | GORE IRRIGATION SET W. L. Gore & Associates, Inc. | FPA |
| Jun 4, 1997 | K971066 | TAMARYN I.V. FLOW REGULATOR EXTENSION SET Tamaryn Medical Systems, Inc. | FPA |
| May 6, 1997 | K970909 | SAFE-CONNECT I.V. SET Faulding Medical Device Co. | FPA |
| May 1, 1997 | K971266 | SAFE-CONNECT Y-SITE ADAPTER CATALOG NO. 681518 Faulding Medical Device Co. | FPA |
| Apr 22, 1997 | K970524 | SAFE-CONNECT I.V. EXTENSION SET Faulding Medical Device Co. | FPA |
| Apr 21, 1997 | K970485 | SMARTSITE ACCESS PIN Ivac Medical Systems | FPA |
| Apr 14, 1997 | K970255 | KIPP MED I.V. MANIFOLD The Kipp Group | FPA |
| Apr 14, 1997 | K964918 | NIMA NEEDLELESS INJECTIONSITE MASTER ADAPTER WITH POSIFLOW POSITIVE DISPLACEMENT FEATURE, AND I.V. SETS Critical Device Corp. | FPA |
| Apr 8, 1997 | K970259 | E-Z SET INFUSION SET/SAF-T E-Z SET INFUSION SET Becton Dickinson Vascular Access, Inc. | FPA |
| Apr 2, 1997 | K970800 | MAXCESS NEEDLEFREE - Y- SITE (100713) Solopak Medical Products, Inc. | FPA |
| Apr 2, 1997 | K970438 | INTERLINK MICRO-INFUSION MANIFOLD EXTENSION SETS Baxter Healthcare Corp | FPA |
| Mar 27, 1997 | K970076 | NIPRO DISPOSABLE SOLUTION INFUSION SET Nipro Medical Corp. | FPA |
| Mar 24, 1997 | K964844 | CONMED: STAT 2 AND STAT 2 PUMPETTE EXTENSION SETS AND MASTERFLOW AND MASTERFLOW PUMPETTE PRIMARY SETS Conmedcorp | FPA |
| Feb 28, 1997 | K964876 | SA.EF(TM) INFUSION PORT II - CONNECTOR AND EXTENSION SET Vlv Associates, Inc. | FPA |
| Feb 27, 1997 | K964968 | MR EXTENSION SET (001) University of Michigan | FPA |
| Feb 25, 1997 | K964850 | SOLUTION ADMINISTRATION SET WITH 0.22 MICRON HIGH PRESSURE EXTENDED LIFE FILTER Baxter Healthcare Corp | FPA |
| Feb 14, 1997 | K963981 | VYGON BIONECTOR WITH EXTENSION SET Vygon Corp. | FPA |
| Feb 10, 1997 | K964812 | NIMA NEEDLELESS INJECTIONSITE MASTER ADAPTER AND I.V. SET Critical Device Corp. | FPA |
| Jan 30, 1997 | K964456 | POLYFIN QR WITH WINGS INFUSION SETS, MODELS 365, 366, AND 367 Medtronic Minimed | FPA |
| Jan 30, 1997 | K964455 | POLYFIN WITH WINGS INFUSION SETS, MODELS 306, 307, 333 Medtronic Minimed | FPA |
| Jan 27, 1997 | K964384 | MODEL D-290P ADMINISTRATION SET Patient Solutions, Inc. | FPA |
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