ClearanceBrief
510(k) K071538 ยท FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER

ApplicantArrow International, Inc., Reading PA, US
DecisionSubstantially Equivalent, Aug 30, 2007
ReceivedJun 5, 2007
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K071538

DateFirm and productCodeLinked 510(k)
Jun 13, 2026ARROW INTERNATIONAL, LLC
Description/REF: CVC/PSI KIT: 2 LUMEN 8 FR X 6 IN/ASK-42802-PLH; CVC KIT: 3-LUMEN 12 FR X 16 CM/AK-12123-F; CVC KIT: 3-LUMEN 12 FR X 20 CM/AK-15123-F; 3L CVC KIT: 7 FR X 16 CM/ASK-12703-PMAH; 3L PI CV
Open, Classified
LRSNone listed
May 7, 2026Medline Industries, LP
Medline Convenience Kits: 1) KIT TRIPLE LUMEN INSERTION, Model Number: DYNDM1031A
Open, Classified
FOZNone listed
Apr 22, 2026ARROW INTERNATIONAL, LLC
ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER REF ASK-42802-PLH UDI code: (01)10801902133110(17)261231(11)251211(10)33F25L0140 REF ASK-45703-MGH UDI code: (
Open, Classified
FOZNone listed
Oct 5, 2023ARROW INTERNATIONAL Inc.
Arrow ErgoPack Complete, Pressure Injectable Arrowg+ard Blue Plus Four-Lumen CVC, REF CDC-42854- PCN1A; catheter, intravascular, therapeutic, long-term greater than 30 days
Open, Classified
FOZNone listed
Oct 5, 2023ARROW INTERNATIONAL Inc.
Arrow Pressure Injectable Arrowg+ard Blue Plus Four-Lumen CVC, REF CDC-45854-P1A; catheter, intravascular, therapeutic, long-term greater than 30 days
Open, Classified
FOZNone 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
Aug 26, 2022Mckesson Medical-Surgical Inc. Corporate Office
TELEFLEX LLC Arrow Central Venous Catheter Kit 16, 18 Gauge Multi Lumen Model Number:CDC-45703-XP1A (Model Numbers # IPN035619, IPN036437, IPN922677)
Open, Classified
FOZNone listed
Apr 11, 2018Arrow International Inc
Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter, Sharps Safety Features and Maximal Barrier Precautions; Product Code: ASK-15703-LDP1
Terminated
FOZNone listed
Apr 11, 2018Arrow International Inc
Pressure Injectable Multi-Lumen Central Venous Catheterization Kit; Product Code: ASK-15703-PHMC
Terminated
FOZNone listed
Apr 11, 2018Arrow International Inc
Pressure Injectable Multi-Lumen Central Venous Catheterization Kit; Product Code: ASK-15703-PVH and ASK-15703-PNYP
Terminated
FOZNone listed
Apr 11, 2018Arrow International Inc
Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features; Product Codes: ASK-42703-MHW and ASK-42703-OLL1
Terminated
FOZNone listed
Apr 11, 2018Arrow International Inc
Pressure Injectable ARROWg+ard Blue PLUS(R) Multi-Lumen Central Venous Catheterization Kit; Product Codes: ASK-42703-PAM1, ASK-42703-PSHR1, ASK-45703-PNY, ASK-45703-PWHC1
Terminated
FOZNone listed
Apr 11, 2018Arrow International Inc
ARROWg+ard Blue PLUS Pressure Injectable Quad-Lumen CVC Kit; Product Codes: CDC-42854-P1A and CDC-45854-P1A
Terminated
FOZNone listed
Apr 11, 2018Arrow International Inc
Pressure Injectable Two-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features; Product Code: ASK-45802-PHMW
Terminated
FOZNone listed
Apr 11, 2018Arrow International Inc
Pressure Injectable Quad-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features; Product Codes: ASK-45854-PSFM and ASK-42854-PRR
Terminated
FOZNone listed
Apr 11, 2018Arrow International Inc
ARROWg+ard Blue PLUS Pressure Injectable Two-Lumen CVC Kit; Product Code: CDC-42802-P1A
Terminated
FOZNone listed
Apr 11, 2018Arrow International Inc
Pressure Injectable ARROWg+ard Blue PLUS(R) Two-Lumen Central Venous Catheterization Kit; Product Code: ASK-42802-PWHC1
Terminated
FOZNone listed
Apr 11, 2018Arrow International Inc
ARROWg+ard Blue PLUS Pressure Injectable Multi-Lumen CVC Kit; Product Codes: CDC-45703-P1A; CDC-45703-PB1A; CDC-42703-P1A; and CDC-15703-P1A
Terminated
FOZNone listed
Apr 11, 2018Arrow International Inc
Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip, ARROWg+ard Blue PLUS Catheter, Sharps Safety Features and Maximal Barrier Precautions; Product Codes: ASK-45703-LD
Terminated
FOZNone listed
Apr 11, 2018Arrow 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; Product Code: ASK-427
Terminated
FOZNone listed
Apr 11, 2018Arrow International Inc
Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features; Product Codes: ASK-42703-PTJH and ASK-45703-PTJH
Terminated
FOZNone listed
Apr 11, 2018Arrow International Inc
Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter, Sharps Safety Features and Maximal Barrier Precautions; Product Code: ASK-42703-RV1
Terminated
FOZNone listed
Apr 11, 2018Arrow International Inc
Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter, Sharps Safety Features and Maximal Barrier Precautions; Product Code: ASK-42703-RV1
Terminated
FOZNone listed
Apr 11, 2018Arrow International Inc
ARROWg+ard Blue PLUS(R) Multi-Lumen Central Venous Catheterization Kit; Product Code: ASK-42703-SJH
Terminated
FOZNone listed
Mar 5, 2018Arrow International Inc
Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter, Sharps Safety Features and Maximal Barrier Precautions. Permits venous access and catheter introduction
Terminated
FOZNone listed
Mar 5, 2018Arrow 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. Permits venous acc
Terminated
FOZNone listed
Mar 5, 2018Arrow International Inc
Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue FlexTip, ARROWg+ard Blue PLUS Catheter and Sharps Safety Features. Permits venous access to central circulation.
Terminated
FOZNone listed
Mar 5, 2018Arrow International Inc
Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue FlexTip, ARROWg+ard Blue PLUS Catheter, Sharps Safety Features and Maximal Barrier Precautions. Permits venous access to
Terminated
FOZNone listed
Mar 5, 2018Arrow International Inc
Pressure Injectable Two- Lumen Central Venous Catheterization Kit with Blue FlexTip, ARROWg+ard Blue PLUS Catheter and Sharps Safety Features. Permits venous access to central circulation.
Terminated
FOZNone listed
Mar 5, 2018Arrow International Inc
Pressure Injectable Multi- Lumen CVC Kit
Terminated
FOZNone listed
Mar 5, 2018Arrow International Inc
ARROWg+ard Blue PLUS Pressure Injectable Multi-Lumen CVC Kit. Intended to permit venous access to the central circulation.
Terminated
FOZNone listed
Feb 20, 2018Arrow International Inc
Pressure Injectable ARROWg+ard Blue PLUS Multi Lumen Central Venous Catheterization Kit; Product Code: ASK 42703 PUHC; Exp. Dates Feb 2018 - Nov 2018
Terminated
FOZNone listed
Feb 20, 2018Arrow International Inc
Pressure Injectable ARROWg+ard Blue PLUS MultiLumen Central Venous Catheterization Kit; Product Codes: ASK-45703-PNHS; ASK-45703-PGMCL; ASK-45703-PNW; Exp. Dates Feb 2018 - Nov 2018
Terminated
FOZNone listed
Feb 20, 2018Arrow International Inc
Pressure Injectable Multi Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter and Sharps Safety Features; Product Code: ASK-15703-PRWJ; Exp. Dates Feb 2018- Nov 2018
Terminated
FOZNone listed
Feb 20, 2018Arrow International Inc
Pressure Injectable ARROWg+ard Blue PLUS Multi Lumen Central Venous Catheterization Kit; Product code: ASK-45703-PHF2; Exp. Dates Feb 2018 - Nov 2018
Terminated
FOZNone listed
Feb 20, 2018Arrow International Inc
AGB+ Multi Lumen Central Venous Catheterization Kit; Product Codes: CDC-42703-XP1A and CDC-47702-XP1A; Exp. Dates Feb 2018 - Nov 2018
Terminated
FOZNone listed
Dec 22, 2017Arrow International Inc
AGB+ Multi Lumen Central Venous Catheterization (CVC) Kit (1) Part Number: AK-42703-P1A; (2) AK-45703-P1A; (3) AK-45703-PB1A; AGB+ Pressure Injectable Multi-Lumen CVC Kit (4) CA-42703-P1A; (5) CA-4285
Terminated
FOZNone listed
Nov 27, 2017Arrow International Inc
Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter and Sharps Safety Features Product Usage: The Arrow CVC is indicated to provide short-term (< 30 days) central venous acce
Terminated
FOZNone listed
Nov 27, 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 Product Usage: The Arrow CVC is indicated to prov
Terminated
FOZNone listed
Nov 27, 2017Arrow International Inc
Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Product Usage: The Arrow CVC is indicated to provide short-term (< 30 days) central v
Terminated
FOZNone listed
Nov 27, 2017Arrow International Inc
AGB+ Pressure Injectable Multi- Lumen CVC Kit Product Usage: The Arrow CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring centr
Terminated
FOZNone listed
Nov 27, 2017Arrow International Inc
AGB+ Pressure Injectable Quad- Lumen CVC Kit Product Usage: The Arrow CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring centra
Terminated
FOZNone listed
Nov 27, 2017Arrow International Inc
AGB+ Pressure Injectable Multi- Lumen CVC Kit Product Usage: The Arrow CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring centr
Terminated
FOZNone listed
Nov 27, 2017Arrow International Inc
ARROWg+ard BLUE PLUS Pressure Injectable Two- Lumen CVC Kit Product Usage: The Arrow CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions
Terminated
FOZNone listed
Nov 27, 2017Arrow International Inc
ARROWg+ard BLUE PLUS Pressure Injectable Quad- Lumen CVC Kit Product Usage: The Arrow CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions
Terminated
FOZNone listed
May 9, 2017Arrow International Inc
1) Pressure Injectable Multi-Lumen Central Venous Catheterization Kit 2) Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter and Sharps Safety Features 3
Terminated
FOZNone listed
Apr 10, 2017Arrow International Inc
Pressure Injectable Arrowg+ard Blue Plus Multi-Lumen Central Venous Catheterization Kit. Permits venous access to central circulation by way of subclavian, jugular and femoral veins. The ARROWg+ard te
Terminated
FOZNone listed
Jul 6, 2016Arrow 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
FOZNone listed
Feb 10, 2015Arrow 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
FOZNone listed
Jan 22, 2015Arrow International Inc
Multi-Lumen PI CVC Kit and PSI Kit: 3-L 7 FR X 8 product code: ASK-45703-POSU lot #23F13L0166, exp. 31-Jul-2015: Product Usage: Multi-Lumen PI CVC Kit: An intravascular catheter is a device that co
Terminated
FOZNone listed
May 19, 2014Arrow International Inc
Arrowgard Blue and Arrowgard Blue Plus Pressure Injectable Central Venous Catheter, a multiple-lumen catheter that permits venous access to central circulation. Catalog number ASK-45703-PHF.
Terminated
FOZNone listed
Jun 19, 2012Arrow International Inc
Arrow International, Inc. 7FR 3-Lumen Arrowg+ard Blue Plus(R) Pressure Injectable Central Venous Catheter - Catalog number CDC-42703-XP1A The multiple-lumen pressure injectable catheter permits venou
Terminated
FOZNone listed
Sep 25, 2010Arrow International Inc
Multi-Lumen Pressure Injectable Central Venous Catheterization kit with Blue FlexTip Catheter, ARROW g+ard Blue PLUS Catheter and Sharps Safety Features
Terminated
FOZNone listed

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