ClearanceBrief
510(k) K993691 ยท FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

ARROWG +ARD BLUE PLUS ANTIMICROBIAL MULTI-LUMEN CENTRAL VENOUS CATHETER

ApplicantArrow Intl., Inc., Reading PA, US
DecisionSubstantially Equivalent, Mar 8, 2000
ReceivedNov 1, 1999
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K993691

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
Jan 6, 2021Arrow International Inc
Arrow AGB+ Multi-Lumen CVC Kit 7Fr 3 Lumen- Intended for venous access to the central circulation by the way of the femoral, jugular, or subclavian veins. Product Code: CDC-45703-1A
Terminated
FOZNone listed
Jul 18, 2019Arrow International Inc
Arrow AGB+ Multi-Lumen CVC Kit-catheter permits venous access to central circulation by way of subclavian, jugular, and femoral veins Product Code: CDC-42703-1A - Product Usage: The ARROWg+ard Blue PL
Terminated
FOZNone listed
Sep 21, 2018Arrow International Inc
Arrow AGB+ Multi-Lumen CVC Kit, 7 Fr., 3 Lumen, 20cm catheter length, .025 inch dia. spring-wire guide, Product Code CDC-45703-B1A - Product Usage: The multiple-lumen catheter permits venous access to
Terminated
FOZNone listed
Aug 30, 2018Arrow International Inc
Arrow AGB + Multi-Lumen CVC Kit, Cat. No. CDC-42703-B1A. Product Usage - The Arrow CVC is intended to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requi
Terminated
FOZNone listed
Apr 11, 2018Arrow International Inc
Double-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features; Product Codes: ASK-42802-VC and ASK-47702-VC
Terminated
FOZNone listed
Apr 11, 2018Arrow International Inc
Two-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-42802-DMC
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 code: ASK-45703-AEH
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 Codes: ASK-45703-SCH; ASK-45703-
Terminated
FOZNone listed
Apr 11, 2018Arrow International Inc
ARROWgard Blue PLUS Triple-Lumen CVC Kit with Blue FlexTip Catheter; Product Code: ASK-45703-VC
Terminated
FOZNone listed
Mar 21, 2018Arrow International Inc
ARROWg+ard Blue PLUS catheter, Catalog Number: ASK-45854-NG Product Usage: The ARROWg+ard Blue PLUS catheter permits venous access to central circulation by way of subclavian, jugular, and femoral ve
Terminated
FOZNone listed
Feb 20, 2018Arrow International Inc
ARROWg+ard Blue Plus Multi Lumen CVC (Central venous catheter); Product Code: AK-45703-ACDC; Exp. Dates Feb 2018 - Nov 2018
Terminated
FOZNone listed
Dec 22, 2017Arrow International Inc
AGB+ Multi Lumen CVC Kit (1) Part Number (PN): CDC-42703-B1A, (2) PN: CDC-42802-1A, (3) CDC-45703-1A, (4) CDC-45703-A1A, (5) PN: CDC-45703-B1A; AGB+ Quad-Lumen CVC Kit (6) PN: CDC-42854-1A, (7) PN: CD
Terminated
FOZNone listed
May 9, 2017Arrow International Inc
Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features. The multiple-lumen catheter permits venous access to the central circ
Terminated
FOZNone listed
Apr 24, 2014Arrow International Inc
Arrowgard Blue Plus Antimicrobial Multi-lumen Central Venous Catheter, catalogue number AK-45854-CDC.
Terminated
FOZNone listed
Sep 25, 2010Arrow International Inc
Two-Lumen Central Venous Catheterization kit with Blue FlexTip ARROW g+ard Blue PLUS Catheter, Sharps Safety Features, and Maximal Barrier Precautions
Terminated
FOZNone listed
Mar 5, 2010Arrow International Inc
Multi-Lumen Central Venous Catheterization Kit with Blue Flex-Tip(R), ARROWg+ard Blue PLUS (R) Catheter, Sharps Safety Features and Maximal Barrier Precautions. The product is shipped in cases contain
Terminated
FOZNone listed
Mar 5, 2010Arrow International Inc
Two-Lumen Central Venous Catheterization Kit with Blue Flex-Tip(R), ARROWg+ard Blue PLUS (R) Catheter, Sharps Safety Features and Maximal Barrier Precautions. The product is shipped in cases containin
Terminated
FOZNone listed
Mar 5, 2010Arrow International Inc
Multi-Lumen Central Venous Catheterization Kit with Blue Flex-Tip(R), ARROWg+ard Blue PLUS (R) Catheter, Sharps Safety Features and Maximal Barrier Precautions. (contains Q-Syte)
Terminated
FOZNone listed
Mar 5, 2010Arrow International Inc
Multi-Lumen Central Venous Catheterization Kit with Blue Flex-Tip(R), ARROWg+ard Blue PLUS (R) Catheter, Sharps Safety Features and Maximal Barrier Precautions. (contains Q-Syte)
Terminated
FOZNone listed
Jun 24, 2009Arrow International Inc
Arrow ARROWg+ard Blue Plus Multi-Lumen CVCs (Central Venous Catheters)
Terminated
FOZNone listed
Oct 28, 2004Arrow International Inc
Arrowg+ard Blue Two Lumen CVC Super Kit, Catalog number AK-22802-SK. The kit actually contains Arrowg+ard Blue Plus Two Lumen CVC Super Kit. Catalog number AK-42802-SK, 8 Fr x 16 cm Two Lumen Arrowg+a
Terminated
FOZNone listed

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