Panels › General Hospital › Product code FOZ · Class 2
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Regulation 880.5200
8510(k)s in 12 months (508 all time)
6recalls in 12 months (394 all time)
359recalls that name a 510(k)
Top companies in FOZ
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 20, 2017 | Arrow International Inc Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port for use with 7 - 7.5Fr. Catheters
The Arrow Percutaneous Sheath Introducer permits venous access and catheter introduction Terminated |
FOZ | K002507 |
| Mar 20, 2017 | Arrow International Inc "Pressure Injectable Jugular Axillo-Subclavian
Central Catheter (JACC) Product"
The CG+ Arrow JACC powered by Arrow VPS Stylet permits venous access to the central circulation through a central vei Terminated |
FOZ | K002507 |
| Mar 20, 2017 | Arrow International Inc Arrow PICC with Chlorag+ard Technology
A PICC permits venous access to the central circulation through a peripheral vein. The intended use of the VP'S Stylet and Console (VPS System) is to quickly an Terminated |
FOZ | K002507 |
| Mar 20, 2017 | Arrow International Inc Arrow Access Kit with Maximal Barrier Precautions for use with 5 Fr. Peripherally Inserted Central Venous Catheter
The Arrow GlideThru" Peel-Away Sheath/Dilator Introducer is used for the percutane Terminated |
FOZ | K002507 |
| Mar 20, 2017 | Arrow International Inc Arrow Access Kit with Maximal Barrier Precautions for use with 5 Fr. Peripherally Inserted Central Venous Catheter
The Arrow GlideThru" Peel-Away Sheath/Dilator Introducer is used for the percutaneou Terminated |
FOZ | K002507 |
| Mar 20, 2017 | Arrow International Inc Arrow(R) Access Kit for use with 4 Fr. Peripherally Inserted Central Venous Catheter
The Arrow GlideThru" Peel-Away Sheath/Dilator Introducer is used for the percutaneous introduction of diagnostic o Terminated |
FOZ | K002507 |
| Mar 20, 2017 | Arrow International Inc Arrow Access Kit with Maximal Barrier Precautions for use with 4 Fr. Peripherally Inserted Central Venous Catheter
The Arrow GlideThru" Peel-Away Sheath/Dilator Introducer is used for the percutane Terminated |
FOZ | K002507 |
| Mar 20, 2017 | Arrow International Inc Arrow PICC with Chlorag+ard Technology
The ArrowEVOLUTION Pressure Injectable PICC with Chlorag+ard Antimicrobial and Antithrombogenic Technology is indicated for short-term or long-term peripheral a Terminated |
FOZ | K002507 |
| Mar 20, 2017 | Arrow International Inc Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard(R) Technology
The ArrowEVOLUTIONTM Pressure Injectable P1CC with Chlorag+ard Antimicrobial and Antithrombogenic Technology is indicated for sh Terminated |
FOZ | K002507 |
| Mar 20, 2017 | Arrow International Inc Arrow(R) VPS(R) Access Kit for use with 5 Fr. Peripherally Inserted Central Venous Catheter
The intended use of the VPS Stylet and Console (VPS System) is to quickly and accurately guide market a Terminated |
FOZ | K002507 |
| Mar 20, 2017 | Arrow International Inc Arrow VPS Access Kit with Maximal Barrier Precautions for use with 4 Fr. Peripherally Inserted Central Venous Catheter
The intended use of the VPS Stylet and Console (VPS System) is to quickly an Terminated |
FOZ | K002507 |
| Mar 20, 2017 | Arrow International Inc Arrow VPS Access Kit with Maximal Barrier Precautions for use with 5 Fr. Peripherally Inserted Central Venous Catheter
The intended use of the VPS Stylet and Console (VPS System) is to quickly and Terminated |
FOZ | K002507 |
| Mar 20, 2017 | Arrow International Inc Arrow(R) VPS(R) Access Kit for use with 4 Fr. Peripherally Inserted Central Venous Catheter
The intended use of the VPS Stylet and Console (VPS System) is to quickly and accurately guide market avail Terminated |
FOZ | K002507 |
| Mar 20, 2017 | Arrow International Inc Arrow Pressure Injectable PICC Kit
The Arrow International Pressure Injectable PICC is intended for short-term or long-term peripheral access to the central venous system for intravenous therapy an Terminated |
FOZ | K002507 |
| Mar 20, 2017 | Arrow International Inc AGB+ Pressure Injectable Multi-Lumen CVC Kit
The Arrow Central Venous Catheters are intended to permit venous access to the central circulation by way of the femoral, jugular or subclavian veins.The Terminated |
FOZ | K002507 |
| Mar 20, 2017 | Arrow International Inc AGB+ Pressure Injectable Multi-Lumen CVC Kit
intended to permit venous access to the central circulation by way of the femoral, jugular or subclavian veins
intended to permit venous access to the ce Terminated |
FOZ | K002507 |
| Mar 20, 2017 | Arrow International Inc Pressure Injectable Quad-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features
The ARROWg+ard Blue Plus" antimicrobial catheter is Terminated |
FOZ | K002507 |
| Mar 20, 2017 | Arrow International Inc Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter, Sharps Safety Features, and Maximal Barrier Precautions
The ARROWg+ard Blue Terminated |
FOZ | K002507 |
| Mar 20, 2017 | Arrow International Inc Pressure Injectable Two-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter
The ARROWg+ard Blue Plus" antimicrobial catheter is indicated in the short-term Terminated |
FOZ | K002507 |
| Mar 20, 2017 | Arrow International Inc Pressure Injectable ARROWg+ard Blue PLUS(R) Two-Lumen Central Venous Catheterization Kit
The ARROWg+ard Blue Plus" antimicrobial catheter is indicated in the short-term ( < 30 days) treatment of dise Terminated |
FOZ | K002507 |
| Mar 20, 2017 | Arrow International Inc Pressure Injectable Two-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter, Sharps Safety Features and Maximal Barrier Precautions
The ARROWg+ard Blue Plu Terminated |
FOZ | K002507 |
| Mar 20, 2017 | Arrow International Inc Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features
The ARROWg+ard Blue Plus" antimicrobial catheter i Terminated |
FOZ | K002507 |
| Mar 20, 2017 | Arrow International Inc Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter
The ARROWg+ard Blue Plus" antimicrobial catheter is indicated in the short-term ( < 30 days) treatment Terminated |
FOZ | K002507 |
| Mar 20, 2017 | Arrow International Inc ARROWg+ard Blue Large-Bore Multi-Lumen CVC Kit.
The large-bore multiple-lumen catheter permits venous access to the central circulation for rapid fluid administration. It ma be inserted into the jugu Terminated |
FOZ | K002507 |
| Mar 20, 2017 | Arrow International Inc Arrow Pressure Injectable PICC Kit
The Arrow International Pressure Injectable PICC is intended for short-term or long-term peripheral access to the central venous system for intravenous therapy and Terminated |
FOZ | K002507 |
| Mar 20, 2017 | Arrow International Inc Arrow Pressure Injectable PICC Kit
The Arrow International Pressure Injectable PICC is intended for short-term or long-term peripheral access to the central venous system for intravenous therapy and Terminated |
FOZ | K002507 |
| Mar 20, 2017 | Arrow International Inc Pressure injectable Jugular Axillo-Subclavian Central CThe CG+Arrow JACC powered by Arrow VPS Stylet permits venous access to the central circulation through a central veinatheter (JACC) Product Terminated |
FOZ | K002507 |
| Mar 20, 2017 | Arrow International Inc Arrow PICC with Chlorag+ard Technology
A PICC permits venous access to the central circulation through a peripheral vein Terminated |
FOZ | K002507 |
| Mar 20, 2017 | Arrow International Inc ARROWg+ard Blue Large-Bore Multi-Lumen CVC Kit
The large-bore multiple-lumen catheter permits venous access to the central circulation for rapid fluid administration Terminated |
FOZ | K002507 |
| Mar 20, 2017 | Arrow International Inc ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit.
The MAC Two-Lumen Central Venous Access Device with ARROWg+ard Blue permits venous access and catheter introduction to the central circulation Terminated |
FOZ | K002507 |
| Mar 20, 2017 | Arrow International Inc ARROWg+ard Blue PLUS(R) Two-Lumen Central Venous Catheterization Kit.
The Arrow(r) CVC is indicated to provide short-term (<30 days) central venous access for treatment of diseases or conditions requ Terminated |
FOZ | K002507 |
| Mar 20, 2017 | Arrow International Inc Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard(R) Technology
The ArrowEVOLUTIONTM Pressure injectable P1CC with chlorag+ard Antimicrobial and Antithrombogenic Technology is indicated for shor Terminated |
FOZ | K002507 |
| Mar 20, 2017 | Arrow International Inc Percutaneous Sheath Introducer Kit with ARROWg+ard Blue(R) Sheath, Integral Hemostatis Valve/Side Port, Sharps Safety Features and Maximal Barrier Precautions for use with 7.5-8 Fr. Catheters.
The Ar Terminated |
FOZ | K002507 |
| Mar 20, 2017 | Arrow International Inc Two-Lumen Hemodialysis Catheterization Kit with Blue Flex Tip(R), ARROWg+ard Blue(R) Catheter, Sharps Safety Features and Maximal Barrier Precautions for High Volume Infusions.
The MAC(TM) Multi-Lume Terminated |
FOZ | K002507 |
| Mar 20, 2017 | Arrow International Inc MAC(TM) Two-Lumen Central Venous Access Kit with ARROWg+ard Blue (R) Access Device, Integral Hemostasis Valve, Sharps Safety Features and Maximal Barrier Precautions for use with 7.5 -8 Fr. Catheters. Terminated |
FOZ | K002507 |
| Mar 20, 2017 | Arrow International Inc Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter
The Arrow(r) CVC is indicated to provide short-term (<30 days) central venous access for treatment of Terminated |
FOZ | K002507 |
| Mar 20, 2017 | Arrow International Inc Arrow VPS Access Kit with Maximal Barrier Precautions for use with 5 Fr. Peripherally inserted Central Venous Catheter
The Arrow(r) CVC is indicated to provide short-term (<30 days) central venous ac Terminated |
FOZ | K002507 |
| Mar 20, 2017 | Arrow International Inc Arrow Pressure Injectable PICC Kit
The Arrow International Pressure Injectable PICC is intended for short-term or long-term peripheral access to the central venous system for intravenous therapy and Terminated |
FOZ | K002507 |
| Mar 20, 2017 | Arrow International Inc ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit
The MAC(TM) Multi-Lumen Central Venous Access Device with ARROWg+ard Blue(R) permits venous access and catheter introduction to the central cir Terminated |
FOZ | K002507 |
| Mar 20, 2017 | Arrow International Inc ARROWg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters
The MAC(TM) Multi-Lumen Central Venous Access Device with ARROWg+ard Blue(R) permits venous access an Terminated |
FOZ | K002507 |
| Mar 20, 2017 | Arrow International Inc MAC(TM) Two-Lumen Central Venous Access Kit with ARROWg+ard Blue(R) Access Device, Integral Hemostasis Valve, Sharps Safety Features and Maximal Barrier Precautions for use with 7.5 - 8 Fr. Catheters
Terminated |
FOZ | K002507 |
| Dec 19, 2016 | Smiths Medical ASD Inc. Acuvance2 Safety Catheter, Product No. 1720-AI
Product Usage:
The Acuvance 2 Safety Catheter is a Peripheral Intravenous Catheter (PIVC). PIVCs are designed for single use venipuncture on all patient Terminated |
FOZ | K012128 |
| Dec 12, 2016 | Cook Inc. Cook Spectrum Minocycline/Rifampin Impregnated Double Lumen Central Venous Catheter Tray
Cook Spectrum Minocycline/Rifampin Impregnated Triple Lumen Central Venous Catheter Tray Terminated |
FOZ | K033843 |
| Dec 2, 2016 | Centurion Medical Products Corporation Multi-Med Single Lumen Catheters sold in Centurion convenience kits.
The Multi-Med catheter is indicated for use in patients requiring administration of solutions, blood sampling, and central venous p Terminated |
FOZ | K955839 |
| Jul 6, 2016 | Arrow International Inc ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER.
Product Usage:
Indicated to provide short-term (<30 days) central venous access for treatment of diseases or co Terminated |
FOZ | K071538 |
| May 18, 2016 | Becton Dickinson & Company 1) 24 G x 0.75 in. BD Angiocath" Autoguard" shielded IV
catheter (0.7 mm x 19 mm) made of FEP polymer
catalog number 381700
2) 24 G x 0.56 in. BD Angiocath-N" Autoguard" shielded
IV catheter (0.7 Terminated |
FOZ | None listed |
| Sep 30, 2015 | Arrow International Inc Arrow Kits with Medtronic Covidien 0.9% Sodium Chloride Flush Syringes Terminated |
FOZ | K001587 K002507 +3 |
| Aug 5, 2015 | Terumo Medical Corporation SurFlo IV Catheter Terminated |
FOZ | K891087 |
| Mar 13, 2015 | Bard Access Systems BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: PowerGlide Midline Catheter Full Kit (20G) (8cm), PowerGlide Midline Catheter Maximal Barrier Tray (20G) (8cm), PowerGlid Terminated |
FOZ | K121073 K133856 |
| Feb 10, 2015 | Arrow International Inc ARROWg+ard Blue PLUS Pressure Injectable Two-Lumen CVC Kit. The Multiple-Lumen Catheter permits venous access to the central circulation by way of the femoral jugular, or subclavian veins. Terminated |
FOZ | K071538 |
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