ClearanceBrief
510(k) K862056 ยท DQY Catheter, Percutaneous

[CENTRAL VENOUS][MULTI-LUMEN] CATHETER W/FLEX TIP

ApplicantArrow Intl., Inc., Reading PA, US
DecisionSubstantially Equivalent, Aug 25, 1986
ReceivedMay 30, 1986
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K862056

DateFirm and productCodeLinked 510(k)
Jun 13, 2026ARROW INTERNATIONAL, LLC
Description/REF: ARTERIAL LINE KIT: SL 20 GA X 5 IN/ASK-04510-MM6 RA CATH KIT: 20 GA X 1-3/4IN/NA-04020-X1ASP ACCESS TRAY/ASK-04001-MS RA CATH KIT: 20 GA X 8 CM/ASK-00820-UM1 VESSEL CATH KIT: 20GA X 5
Open, Classified
DQYNone listed
Jan 10, 2019Arrow International Inc
Arrow Two-Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter Product Code: AH-11802 (OUS) GTN: 00801902026132
Terminated
DQYNone listed
Jan 10, 2019Arrow International Inc
Arrow Two-Lumen Central Venous Catheterization Set with Blue FlexTip Catheter Product Code: CD-10802 GTN: 00801902015396
Terminated
DQYNone listed
Nov 14, 2018Arrow International Inc
Arrow CVC 2 Lumen, Pediatric Two-Lumen Central Venous Cauterization Set with Blue FlexTip Catheter, 4 Fr 2 Lumen 5cm, Reference # CS-12402 The Arrow CVC is intended to provide short-term (< 30 days)
Terminated
DQYNone listed
Jul 10, 2018Arrow International Inc
HANDS-OFF Multi-Lumen Central Venous Catheter with Blue FlexTip for use only with Arrow One-Piece Percutaneous Sheath Introducer System, Material HO-14702 The central venous catheter permits venous a
Terminated
FOZNone listed
Jul 10, 2018Arrow International Inc
HANDS-OFF Multi-Lumen Central Venous Catheter with Blue FlexTip for use only with Arrow One-Piece Percutaneous Sheath Introducer System, Material HO-14703 The central venous catheter permits venous
Terminated
FOZNone listed
May 11, 2018Arrow International Inc
Multi-Lumen Central Venous Catheterization Set with Blue FlexTip Catheter, CS-15853-E Product CVCs are intended to permit venous access to the central circulation through a single puncture site by wa
Terminated
DQYNone listed
Apr 11, 2018Arrow International Inc
Maximal Barrier Drape; Product Code: ASK-04000-HMC
Terminated
DQYNone listed
Apr 11, 2018Arrow International Inc
Two-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter and Sharps Safety Features; Product Code: ASK-15402-HOP
Terminated
DQYNone listed
Apr 11, 2018Arrow International Inc
ARROWg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7-7.5 Fr. Catheters; Product Code: ASK-21142-WHC2
Terminated
DQYNone listed
Feb 20, 2018Arrow International Inc
Multi Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter and Sharps Safety Features; Product Code: ASK 15703 NYP; Exp. Dates Feb 2018 - Nov 2018
Terminated
DQYNone listed
Feb 20, 2018Arrow International Inc
Multi Lumen Central Venous Catheterization Kit; Product Code: ASK-12703-HH2; Exp. Dates Feb 2018 - Nov 2018
Terminated
DQYNone listed
Feb 20, 2018Arrow International Inc
Multi Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter, Sharps Safety Features, and Maximal Barrier Precautions Features; Product Code: ASK-12703-WMC1; Exp. Dates Feb 2018 - Nov 20
Terminated
DQYNone listed
Feb 20, 2018Arrow International Inc
Arrow Multi Lumen CVC Kit (Central venous catheter); Product Code: CDC-15703-1A; Exp. Dates Feb 2018 - Nov 2018
Terminated
DQYNone listed
Feb 20, 2018Arrow International Inc
Central Venous Catheterization Kit with Blue FlexTip Catheter; Product code: AK-04301; Exp. Dates Feb 2018 - Nov 2018
Terminated
DQYNone listed
Dec 22, 2017Arrow International Inc
(1) Access Tray, Part Number (PN): ASK-04001-MS; Arrow Multi-Lumen CVC Kit (2) PN: CDC-12703-1A; (3) PN: CDC-15703-1A; (4) PN: CDC-15703-B1A; Arrow Two-Lumen CVC Kit (5) PN: CDC-12802-1A; (6) PN: CDC-
Terminated
DQYNone listed
May 9, 2017Arrow International Inc
Arrow Multi-Lumen CVC Kit The Arrow Two-Lumen Central Venous Access device permits venous access and catheter introduction to the central circulation.
Terminated
DQYNone listed
Oct 16, 2014Arrow International Inc
Multi-Lumen Central Venous Catheterization Kit
Terminated
DQYNone listed
Oct 14, 2014Arrow International Inc
Arrow Select Kits (ASK) and Maximal Barrier Precautions Kits (CDC) with BD Medical Posiflush 10mL Saline Flush Syringe.
Terminated
DQYNone listed
Aug 14, 2013Arrow International Inc
Arrow International, Inc. Two-Lumen CVC Kit with Blue Flex Tip Catheter. The multiple lumen catheter permits venous access to the central circulation of patients.
Terminated
DQYNone listed
Jan 12, 2011Arrow International Inc
Arrow-Howes (TM) Multi Lumen Central Venous Catheterization Set with Blue FlexTip(R) Catheter. Catalog #: CV-15703. Permits venous access to the central circulation.
Terminated
DQYNone listed
Jul 7, 2009Arrow International Inc
Arrow Pediatric Two-Lumen Central Venous Catheterization Set with Blue FlexTip Catheter, 5 Fr., 2 Lumen, 13cm catheter length, Catalog number: CS-14502.
Terminated
DQYNone listed
Jun 24, 2009Arrow International Inc
Arrow Multi-Lumen CVC w/ BlueFlex Tip (Central Venous Catheter)
Terminated
DQYNone listed
Nov 1, 2003Arrow International Inc
Arrow central venous catheterization kit, 14 ga x 20 cm
Terminated
KZHNone listed

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