510(k) K862056 ยท DQY Catheter, Percutaneous
[CENTRAL VENOUS][MULTI-LUMEN] CATHETER W/FLEX TIP
| Applicant | Arrow Intl., Inc., Reading PA, US |
| Decision | Substantially Equivalent, Aug 25, 1986 |
| Received | May 30, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K862056
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 13, 2026 | ARROW 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 |
DQY | None listed |
| Jan 10, 2019 | Arrow International Inc Arrow Two-Lumen Central Venous Catheterization
Kit with Blue FlexTip Catheter
Product Code: AH-11802 (OUS)
GTN: 00801902026132 Terminated |
DQY | None listed |
| Jan 10, 2019 | Arrow International Inc Arrow Two-Lumen Central Venous Catheterization
Set with Blue FlexTip Catheter
Product Code: CD-10802
GTN: 00801902015396 Terminated |
DQY | None listed |
| Nov 14, 2018 | Arrow 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 |
DQY | None listed |
| Jul 10, 2018 | Arrow 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 |
FOZ | None listed |
| Jul 10, 2018 | Arrow 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 |
FOZ | None listed |
| May 11, 2018 | Arrow 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 |
DQY | None listed |
| Apr 11, 2018 | Arrow International Inc Maximal Barrier Drape; Product Code: ASK-04000-HMC Terminated |
DQY | None listed |
| Apr 11, 2018 | Arrow International Inc Two-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter and Sharps Safety Features; Product Code: ASK-15402-HOP Terminated |
DQY | None listed |
| Apr 11, 2018 | Arrow 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 |
DQY | None listed |
| Feb 20, 2018 | Arrow 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 |
DQY | None listed |
| Feb 20, 2018 | Arrow International Inc Multi Lumen Central Venous Catheterization Kit; Product Code: ASK-12703-HH2; Exp. Dates Feb 2018 - Nov 2018 Terminated |
DQY | None listed |
| Feb 20, 2018 | Arrow 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 |
DQY | None listed |
| Feb 20, 2018 | Arrow International Inc Arrow Multi Lumen CVC Kit (Central venous catheter); Product Code: CDC-15703-1A; Exp. Dates Feb 2018 - Nov 2018 Terminated |
DQY | None listed |
| Feb 20, 2018 | Arrow International Inc Central Venous Catheterization Kit with Blue FlexTip Catheter; Product code: AK-04301; Exp. Dates Feb 2018 - Nov 2018 Terminated |
DQY | None listed |
| Dec 22, 2017 | Arrow 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 |
DQY | None listed |
| May 9, 2017 | Arrow 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 |
DQY | None listed |
| Oct 16, 2014 | Arrow International Inc Multi-Lumen Central Venous Catheterization
Kit Terminated |
DQY | None listed |
| Oct 14, 2014 | Arrow International Inc Arrow Select Kits (ASK) and Maximal Barrier Precautions Kits (CDC) with BD Medical Posiflush 10mL Saline Flush Syringe. Terminated |
DQY | None listed |
| Aug 14, 2013 | Arrow 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 |
DQY | None listed |
| Jan 12, 2011 | Arrow 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 |
DQY | None listed |
| Jul 7, 2009 | Arrow 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 |
DQY | None listed |
| Jun 24, 2009 | Arrow International Inc Arrow Multi-Lumen CVC w/ BlueFlex Tip (Central Venous Catheter) Terminated |
DQY | None listed |
| Nov 1, 2003 | Arrow International Inc Arrow central venous catheterization kit, 14 ga x 20 cm Terminated |
KZH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.