ClearanceBrief
510(k) K002507 ยท DYB Introducer, Catheter

TWO-LUMEN CENTRAL VENOUS ACCESS KIT WITH HEMOSTASIS VALVE/SIDE PORT

ApplicantArrow Intl., Inc., Reading PA, US
DecisionSubstantially Equivalent, Mar 21, 2001
ReceivedAug 15, 2000
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K002507

DateFirm and productCodeLinked 510(k)
Jun 13, 2026ARROW INTERNATIONAL, LLC
Description/REF: ACCESS TRAY/GU-04020; PSI KIT: 8.5 FR/AK-09803-CDC; PSI KIT: 9 FR/AK-09903-CDC; PSI KIT: 8.5 FR X 4 IN (10 CM)/ASK-09810-PCMH1; PSI KIT: 9 FR X 10 CM/ASK-09903-KH; PSI KIT: 9 FR X 10
Open, Classified
DYBNone listed
Dec 10, 2022ARROW INTERNATIONAL Inc.
Arrow MAC Two-Lumen Central Venous Access Kit fr use with 7 - 7.5 Fr Catheters, REF ASK-11242-UPM1; catheter introducer
Terminated
FOZNone listed
Dec 10, 2022ARROW INTERNATIONAL Inc.
Pressure Injectable Arrowg+ard Blue Plus Three-Lumen CVC Kit, REF numbers: a) ASK-42703-NS, b) ASK-42703-PCCH2, c) ASK-42703-PUPM1, d) ASK-45703-NS, e) ASK-45703-PAU, f) ASK-45703-PCAM1, g) ASK-45703-
Terminated
FOZNone listed
Dec 22, 2017Arrow International Inc
(1) MAC Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters, Product Number: ASK-11242-PHP; (2) Arrow MAC" Two- Lumen Central Venous Access Kit, Product Number: CDC-11242-1A
Terminated
FOZNone listed
May 9, 2017Arrow International Inc
Arrow MAC Two-Lumen Central Venous Access Kit Introducer Catheter The Arrow Two-Lumen Central Venous Access device permits venous access and catheter introduction to the central circulation
Terminated
FOZNone listed
Mar 20, 2017Arrow 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
FOZNone listed
Mar 20, 2017Arrow 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
FOZNone listed
Mar 20, 2017Arrow 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
FOZNone listed
Mar 20, 2017Arrow 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
FOZNone listed
Mar 20, 2017Arrow 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
FOZNone listed
Mar 20, 2017Arrow 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
FOZNone listed
Mar 20, 2017Arrow 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
FOZNone listed
Mar 20, 2017Arrow 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
FOZNone listed
Mar 20, 2017Arrow 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
FOZNone listed
Mar 20, 2017Arrow 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
FOZNone listed
Mar 20, 2017Arrow 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
FOZNone listed
Mar 20, 2017Arrow 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
FOZNone listed
Mar 20, 2017Arrow 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
FOZNone listed
Mar 20, 2017Arrow International Inc
Arrow PICC with Chlorag+ard Technology A PICC permits venous access to the central circulation through a peripheral vein
Terminated
FOZNone listed
Mar 20, 2017Arrow 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
FOZNone listed
Mar 20, 2017Arrow 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
FOZNone listed
Mar 20, 2017Arrow 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
FOZNone listed
Mar 20, 2017Arrow 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
FOZNone listed
Mar 20, 2017Arrow 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
FOZNone listed
Mar 20, 2017Arrow 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
FOZNone listed
Mar 20, 2017Arrow 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
FOZNone listed
Mar 20, 2017Arrow 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
FOZNone listed
Mar 20, 2017Arrow 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
FOZNone listed
Mar 20, 2017Arrow 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
FOZNone listed
Mar 20, 2017Arrow 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
FOZNone listed
Mar 20, 2017Arrow 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
FOZNone listed
Mar 20, 2017Arrow 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
FOZNone listed
Mar 20, 2017Arrow 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
FOZNone listed
Mar 20, 2017Arrow 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
FOZNone listed
Mar 20, 2017Arrow 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
FOZNone listed
Mar 20, 2017Arrow 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
FOZNone listed
Mar 20, 2017Arrow 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
FOZNone listed
Mar 20, 2017Arrow 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
FOZNone listed
Mar 20, 2017Arrow 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
FOZNone listed
Mar 20, 2017Arrow 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
FOZNone listed
Mar 20, 2017Arrow 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
FOZNone listed
Mar 20, 2017Arrow 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
FOZNone listed
Mar 20, 2017Arrow 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
FOZNone listed
Mar 20, 2017Arrow 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
FOZNone listed
Mar 20, 2017Arrow 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
FOZNone listed
Mar 20, 2017Arrow 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
FOZNone listed
Mar 20, 2017Arrow International Inc
Femoral Arterial Line Catheterization Kit The Arrow Arterial Catheterization device permits access to the peripheral arterial circulation or to other small vessels
Terminated
FOZNone listed
Mar 20, 2017Arrow International Inc
Femoral Arterial Line Catheterization Kit The Arrow Arterial Catheterization device permits access to the peripheral arterial circulation or to other small vessels
Terminated
FOZNone listed
Mar 20, 2017Arrow International Inc
Radial Artery Catheterization Kit with Sharps Safety Features The Arrow Arterial Catheterization device permits access to the peripheral arterial circulation or to other small vessels
Terminated
FOZNone listed
Mar 20, 2017Arrow International Inc
Radial Artery Catheterization Kit with Sharps Safety Features The Arrow Arterial Catheterization device permits access to the peripheral arterial circulation or to other small vessels
Terminated
FOZNone listed
Mar 20, 2017Arrow International Inc
QuickFlash Radial Artery/Arterial Line Catheterization Kit The Arrow Arterial Catheterization device permits access to the peripheral arterial circulation or to other small vessels
Terminated
FOZNone listed
Mar 20, 2017Arrow International Inc
Arterial Catheterization Kit with Maximal Barrier Precautions The Arrow Arterial Catheterization device permits access to the peripheral arterial circulation or to other small vessels
Terminated
FOZNone listed
Mar 20, 2017Arrow International Inc
Arterial Catheterization Kit The Arrow Arterial Catheterization device permits access to the peripheral arterial circulation or to other small vessels
Terminated
FOZNone listed
Mar 20, 2017Arrow International Inc
QuickFlash(R) Radial Artery/Arterial Line Catheterization Kit The Arrow Arterial Catheterization device permits access to the peripheral arterial circulation or to other small vessels
Terminated
FOZNone listed
Mar 20, 2017Arrow International Inc
Arterial Line Kit with Sharps Safety Features and Maximal Barrier Precautions The Arrow Arterial Catheterization device permits access to the peripheral arterial circulation or to other small vessels
Terminated
FOZNone listed
Mar 20, 2017Arrow 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 may be inserted into the ju
Terminated
FOZNone listed
Mar 20, 2017Arrow International Inc
Percutaneous Sheath Introducer Kit with ARROWg+ard Blue(R) Sheath, Integral Hemostasis Valve/Side Port, Sharps Safety Features and Maximal Barrier Precautions for use with 7.5-8 Fr. Catheters The A
Terminated
FOZNone listed
Mar 20, 2017Arrow 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 req
Terminated
FOZNone listed
Mar 20, 2017Arrow International Inc
Two-Lumen Hemodialysis Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue(R) Catheter, Sharps Safety Features and Maximal Barrier Precautions for High Volume Infusions The Arrow(r) CVC is indi
Terminated
FOZNone listed
Mar 20, 2017Arrow International Inc
ARROWg+ard Blue You-Bend Two-Lumen Hemodialysis Catheterization Kit for High Volume Infusions The Arrow(r) CVC is indicated to provide short-term ( < 30 days) central venous access for treatment of d
Terminated
FOZNone listed
Mar 20, 2017Arrow International Inc
ARROWg+ard Blue You-Bend Two-Lumen Hemodialysis Catheterization Kit for High Volume Infusions The Arrow(r) CVC is indicated to provide short-term ( < 30 days) central venous access for treatment of d
Terminated
FOZNone listed
Sep 30, 2015Arrow International Inc
Arrow Kits with Medtronic Covidien 0.9% Sodium Chloride Flush Syringes
Terminated
FOZNone listed
Sep 25, 2010Arrow International Inc
MAC Two-Lumen Central Venous Access kit with Integral Hemostasis Valve for use with 7 - 8 Fr. Catheters
Terminated
DYBNone listed
Jun 24, 2009Arrow International Inc
Arrow Two-Lumen Central Venous Access (MAC)
Terminated
DYBNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.