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 |
|---|---|---|---|
| Jan 4, 2000 | K993463 | INTRAVASCULAR ADMINISTRATION SET Custom Assemblies, Inc. | FPA |
| Nov 5, 1999 | K993187 | SHELLY PROTECTED AV FISTULA NEEDLE Diasol, Inc. | FPA |
| Nov 5, 1999 | K992999 | DAISY PROTECTED SCALP VEIN SET Diasol, Inc. | FPA |
| Nov 2, 1999 | K993147 | DECAP The Kipp Group | FPA |
| Oct 27, 1999 | K992266 | IV ADMINISTRATION SET New Alliance of Independent Medical Distributors, | FPA |
| Oct 14, 1999 | K992145 | ECOMED SCALP VEIN SET Greiner Meditech, Inc. | FPA |
| Sep 15, 1999 | K992268 | NAC PRN NEEDLELESS ACCESS CONNECTOR The Kipp Group | FPA |
| Sep 15, 1999 | K992072 | BOLUS ACCESSORY SET I-Flow Corp. | FPA |
| Sep 3, 1999 | K991979 | SOF-SET MICRO QR INFUSION SET, MODELS 320 AND 321 Medtronic Minimed | FPA |
| Sep 2, 1999 | K991112 | SAGE CONTRAST MANAGEMENT SYSTEM Sage Laboratories, Inc. | FPA |
| Aug 25, 1999 | K990777 | MED-RX EXTENSION SETS Benlan, Inc., CA | FPA |
| Aug 23, 1999 | K992104 | PARSET, MODEL A10001E Rd Medical Mfg., Inc. | FPA |
| Aug 20, 1999 | K991985 | COOK HIGH VOLUME INFUSION ADAPTER INTRAVASCULAR ADMINISTRATION SET Cook, Inc. | FPA |
| Aug 20, 1999 | K991932 | INTRAVASCULAR ADMINISTRATION SET The Kipp Group | FPA |
| Aug 12, 1999 | K984569 | AB2 MED-FLO SOLUTION SET Ab2 Medical Products, Llp | FPA |
| Jul 26, 1999 | K984060 | LUER ACCESS INJECTION SITE Baxter Healthcare Corp | FPA |
| Jul 1, 1999 | K990496 | ANESFLOW-DUAL DRIP IV INFUSION SET Innovative Design Assoc. | FPA |
| Jun 25, 1999 | K991759 | MAERSK MEDICAL CONTOUR INFUSION SET Maersk Medical A/S | FPA |
| Jun 24, 1999 | K991653 | INVISION-PLUS INJECTION PORT CONNECTOR SYSTEM Rymed Technologies, Inc. | FPA |
| Jun 21, 1999 | K991513 | HOMEPUMP C-SERIES AND HOMEPUMP C-SERIES ONE-STEP KVO I-Flow Corp. | FPA |
| Jun 15, 1999 | K991599 | CADD ADMINISTRATION SET Sims Deltec, Inc. | FPA |
| Jun 9, 1999 | K991301 | CADD-PRIZM HIGH VOLUME ADMINISTRATION SET WITH 1.2 U FILTER AND ADD-ON ANTI-SIPHON VALVE, CADD ADMINISTRATION SET WITH 1 Sims Deltec, Inc. | FPA |
| Jun 9, 1999 | K991255 | CADD-TPN ADMINISTRATION SET, MODEL 21-7071 Sims Deltec, Inc. | FPA |
| May 14, 1999 | K990693 | FLEXNEEDLE PLUS Act Medical, Inc. | FPA |
| Mar 29, 1999 | K990388 | TUTOPLUS IV ADMINISTRATION SET Myco Medical Supplies, Inc. | FPA |
| Mar 1, 1999 | K982098 | TUTODROP 1 AND TUTODROP 2 Myco Medical Supplies, Inc. | FPA |
| Feb 24, 1999 | K990288 | FREE FLOW SAFETY DEVICE, MODEL MG 245052 Teva Medical, Ltd. | FPA |
| Feb 22, 1999 | K984441 | KVO CHECK VALVE ACCESSORY, MODEL EV-0001 I-Flow Corp. | FPA |
| Feb 19, 1999 | K984381 | BURETROL SOLUTION SETS Baxter Healthcare Corp | FPA |
| Feb 12, 1999 | K990083 | CADD ADMINISTRATION SET, CADD 250ML FLEXIBLE MEDICATION RESERVOIR, MODIFIED SECURIT SHELL, SECURITY SHELL ADAPTER Sims Deltec, Inc. | FPA |
| Feb 9, 1999 | K984638 | PARAGON BOLUS ACCESSORY SET I-Flow Corp. | FPA |
| Feb 9, 1999 | K984146 | PARAGON INFUSION I-Flow Corp. | FPA |
| Feb 9, 1999 | K984063 | PARAGON BASAL/BOLUS ADMINISTRATION SET I-Flow Corp. | FPA |
| Feb 9, 1999 | K983411 | COLORVEES IV SET 20 DROPS/ML 105, 60 DROPS/ML 105, VENTED 20 DROPS 105, VENTED 60 DROPS 105 Valnet Medical Corp. | FPA |
| Feb 4, 1999 | K984561 | SUBCUTANEOUS INFUSION SETS, MSR MODEL A & B Msr, Inc. | FPA |
| Jan 20, 1999 | K983926 | MPS GRAVITY FLOW CONTROL SET Critical Device Corp. | FPA |
| Jan 20, 1999 | K983217 | ROWE DUAL-CHECK VALVE Cook, Inc. | FPA |
| Dec 16, 1998 | K983073 | I.V. EXTENSION SET OR I.V. ADMINISTRATION SET Integra Biotechnical, LLC | FPA |
| Sep 4, 1998 | K982672 | COLLEAGUE PUMP SYRINGE ADAPTER SET Baxter Healthcare Corp | FPA |
| Aug 24, 1998 | K982587 | MPS FIXED FLOW RATE SET Medical Product Specialists | FPA |
| Aug 17, 1998 | K981792 | SOLUTION ADMINISTRATION SET Baxter Healthcare Corp | FPA |
| Jul 28, 1998 | K981683 | HUBER NEEDLE INFUSION SET MODEL #20G01 & Y-SITE MODEL #20G01Y Venusa , Ltd. | FPA |
| Jul 21, 1998 | K982123 | CONTRAST CONTROL DEVICE Medex, Inc. | FPA |
| Jul 21, 1998 | K982047 | MPS HUBER NEEDLE EXTENSION SET Medical Product Specialists | FPA |
| Jun 29, 1998 | K981386 | MANAN BLUNT NEEDLE Manan Medical Products, Inc. | FPA |
| Jun 18, 1998 | K981548 | NFC NEEDLEFREE CONNECTOR MODEL 69900 Filtertek, Inc. | FPA |
| Jun 18, 1998 | K981547 | NFC NEEDLEFREE Y-SITE, MODEL 69970 Filtertek, Inc. | FPA |
| Jun 16, 1998 | K981157 | STABLE FLOW Cmed | FPA |
| May 29, 1998 | K980994 | IV ADMINISTRATION SETS WITH NEEDLE ACCESS DEVICES Venetec Intl., Inc. | FPA |
| May 28, 1998 | K980992 | IV ADMINISTRATION SETS WITH NEEDLELESS ACCESS DEVICES Venetec Intl., Inc. | FPA |
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