[CENTRAL VENOUS][MULTI-LUMEN] CATHETER W/FLEX TIP— 510(k) K862056
Substantially EquivalentArrow Intl., Inc.
FDA 510(k) clearance K862056 for [CENTRAL VENOUS][MULTI-LUMEN] CATHETER W/FLEX TIP, Substantially Equivalent on 1986-08-25. Applicant: Arrow Intl., Inc.. Device class: 2.
Clearance details
- Applicant
- Arrow Intl., Inc.
- Product code
- Code DQY
- Device class
- Class 2
- Regulation
- 21 CFR 870.1250
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Reading, PA, US
Recent devices under product code DQY
view allMore clearances from Arrow Intl., Inc.
view all- K100635 — ARROWGARD EVOLUTION ANTIMICROBIAL PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) MODEL: S-44041-002, S-45041-002, S-45504
- K093050 — ARROW SELDINGER ARTERIAL CATHERIZATION DEVICES, MODELS EX SAC 00520
- K071491 — ARROW INTERNATIONAL, INC., SURGICAL DRAPES
- K071998 — ARROW ECHOGENIC INTRODUCER NEEDLE COMPONENT
- K071111 — NON-ABSORBABLE SILK SUTURE
Adverse events under product code DQY
product code DQY- Death
- 464
- Injury
- 4,489
- Malfunction
- 13,721
- Other
- 2
- Total
- 18,676
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K862056
K-number listed on FDA's recall record- Z-2377-2026 — 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 5IN/AK-04550-S CVC KIT: 1-LUMEN 5 FR X 20 CM/AK-04301-SP CVC KIT: 16 GA X 6IN (16 CM)/AK-04306-SP CVC KIT: 16GA X 6 IN/AK-04800-S CVC KIT: 2-LUMEN 4 FR X 5 CM/AK-12402 CVC KIT: 3-LUMEN 7 FR X 16 CM/AK-12703-CDC CVC KIT: 2L 4 FR X 13 CM/AK-14402 CVC KIT: 2-LUMEN 5 FR X 13 CM/AK-14502 CVC KIT: 3-LUMEN 5.5 FR X 30 CM/AK-14553 CVC KIT: 3-LUMEN 7 FR X 30 CM/AK-14703-SP CVC KIT: 2-LUMEN 4 FR X 8 CM/AK-15402 CVC KIT: 3-LUMEN 5.5 FR X 8 CM/AK-15553 CVC KIT: 2-LUMEN 4 FR X 30 CM/AK-16402 CVC KIT: 3-LUMEN 5.5 FR X 13 CM/AK-16553 CVC KIT: 5 FR X 20 CM/ASK-04301-HH2 CVC KIT 3L: 7 FR X 6 IN (16 CM)/ASK-12703-MGH3
- Z-1118-2019 — Arrow¿ Two-Lumen Central Venous Catheterization Kit with Blue FlexTip¿ Catheter Product Code: AH-11802 (OUS) GTN: 00801902026132
- Z-1119-2019 — Arrow¿ Two-Lumen Central Venous Catheterization Set with Blue FlexTip¿ Catheter Product Code: CD-10802 GTN: 00801902015396
- Z-0723-2019 — 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) central venous access for treatment of diseases or conditions requiring central venous access, including, but not limited to the following: " Lack of usable peripheral IV sites " Central venous pressure monitoring " Total parenteral nutrition (TPN) " Infusions of fluids, medications, or chemotherapy " Frequent blood sampling or receiving blood transfusions/blood products
- Z-2818-2018 — 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 access to the central circulation through an indwelling Arrow percutaneous sheath introducer.
- Z-2819-2018 — 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 access to the central circulation through an indwelling Arrow percutaneous sheath introducer.
- Z-2336-2018 — 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 way of the femoral, jugular, or subclavian veins.
- Z-1967-2018 — Maximal Barrier Drape; Product Code: ASK-04000-HMC
- Z-1978-2018 — Two-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter and Sharps Safety Features; Product Code: ASK-15402-HOP
- Z-1982-2018 — 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
- Z-1332-2018 — (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-15802-1A; (7) PN: CDC-17702-1A
- Z-0648-2018 — 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
- Z-0650-2018 — Multi Lumen Central Venous Catheterization Kit; Product Code: ASK-12703-HH2; Exp. Dates Feb 2018 - Nov 2018
- Z-0652-2018 — 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 2018
- Z-0654-2018 — Arrow Multi Lumen CVC Kit (Central venous catheter); Product Code: CDC-15703-1A; Exp. Dates Feb 2018 - Nov 2018
- Z-0657-2018 — Central Venous Catheterization Kit with Blue FlexTip Catheter; Product code: AK-04301; Exp. Dates Feb 2018 - Nov 2018
- Z-2336-2017 — Arrow Multi-Lumen CVC Kit The Arrow Two-Lumen Central Venous Access device permits venous access and catheter introduction to the central circulation.
- Z-0076-2015 — Multi-Lumen Central Venous Catheterization Kit
- Z-0066-2015 — Arrow Select Kits (ASK) and Maximal Barrier Precautions Kits (CDC) with BD Medical Posiflush 10mL Saline Flush Syringe.
- Z-1965-2013 — 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.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K862056.
Data sourced from openFDA. This site is unofficial and independent of the FDA.