510(k) K002507 ยท DYB Introducer, Catheter
TWO-LUMEN CENTRAL VENOUS ACCESS KIT WITH HEMOSTASIS VALVE/SIDE PORT
| Applicant | Arrow Intl., Inc., Reading PA, US |
| Decision | Substantially Equivalent, Mar 21, 2001 |
| Received | Aug 15, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K002507
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 13, 2026 | ARROW 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 |
DYB | None listed |
| Dec 10, 2022 | ARROW 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 |
FOZ | None listed |
| Dec 10, 2022 | ARROW 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 |
FOZ | None listed |
| Dec 22, 2017 | Arrow 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 |
FOZ | None listed |
| May 9, 2017 | Arrow 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 |
FOZ | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| Mar 20, 2017 | Arrow 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 |
FOZ | None listed |
| Mar 20, 2017 | Arrow 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 |
FOZ | None listed |
| Mar 20, 2017 | Arrow 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 |
FOZ | None listed |
| Mar 20, 2017 | Arrow 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 |
FOZ | None listed |
| Mar 20, 2017 | Arrow 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 |
FOZ | None listed |
| Mar 20, 2017 | Arrow 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 |
FOZ | None listed |
| Mar 20, 2017 | Arrow International Inc Arterial Catheterization Kit
The Arrow Arterial Catheterization device permits access to the peripheral arterial circulation or to other small vessels Terminated |
FOZ | None listed |
| Mar 20, 2017 | Arrow 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 |
FOZ | None listed |
| Mar 20, 2017 | Arrow 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 |
FOZ | None listed |
| 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 may be inserted into the ju Terminated |
FOZ | None listed |
| Mar 20, 2017 | Arrow 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 |
FOZ | None listed |
| 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 req Terminated |
FOZ | None listed |
| Mar 20, 2017 | Arrow 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 |
FOZ | None listed |
| Mar 20, 2017 | Arrow 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 |
FOZ | None listed |
| Mar 20, 2017 | Arrow 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 |
FOZ | None listed |
| Sep 30, 2015 | Arrow International Inc Arrow Kits with Medtronic Covidien 0.9% Sodium Chloride Flush Syringes Terminated |
FOZ | None listed |
| Sep 25, 2010 | Arrow International Inc MAC Two-Lumen Central Venous Access kit with Integral Hemostasis Valve for use with 7 - 8 Fr. Catheters Terminated |
DYB | None listed |
| Jun 24, 2009 | Arrow International Inc Arrow Two-Lumen Central Venous Access (MAC) Terminated |
DYB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.