# K862056: [Central Venous][Multi-Lumen] Catheter W/Flex Tip

- Pathway: 510(k) (Traditional)
- Applicant: Arrow Intl., Inc.
- Decided: Aug 25, 1986 after 87 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: 24 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
151 later devices descend from it; 3 cite it directly.
17 of 152 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K992198: Urethane Picc Line Model Upics- (1999), 136 descendants of its own
- K021557: Spectrum Silicone Catheter (2003), 126 descendants of its own
- K051991: Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and Power Line (2005), 119 descendants of its own
- K070996: 4 FR Single Lumen (SL) Powerpicc Catheter (2007), 66 descendants of its own
- K061179: Powerhickman Long-Term Intravascular Catheter (2006), 47 descendants of its own

## Recalls of this device
- Apr 21, 2026 · Class I · Z-2377-2026: Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffect
- Jan 10, 2019 · Class II · Z-1118-2019: The product lidstock contains a labelling error. The lidstock states the incorrect priming volume. The priming volumes printed on the extension lines are correct
- Jan 10, 2019 · Class II · Z-1119-2019: The product lidstock contains a labelling error. The lidstock states the incorrect priming volume. The priming volumes printed on the extension lines are correct
- Nov 14, 2018 · Class II · Z-0723-2019: The lidstock states the incorrect priming volume and flow rates.
- Jul 10, 2018 · Class II · Z-2819-2018: The packaging may not be sealed. If the packaging is compromised in this manner, the sterility of the product cannot be guaranteed.
- Jul 10, 2018 · Class II · Z-2818-2018: The packaging may not be sealed. If the packaging is compromised in this manner, the sterility of the product cannot be guaranteed.
- May 11, 2018 · Class II · Z-2336-2018: The recalling firm has received complaints related to increased resistance encountered when introducing the CVC over the spring wire guide. This may lead to procedural delay, and there may be need of 
- Apr 11, 2018 · Class II · Z-1982-2018: Product sterility may be compromised due to unsealed packaging.
- Apr 11, 2018 · Class II · Z-1978-2018: Product sterility may be compromised due to unsealed packaging.
- Apr 11, 2018 · Class II · Z-1967-2018: Product sterility may be compromised due to unsealed packaging.
- Dec 22, 2017 · Class II · Z-1332-2018: Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.
- Oct 17, 2017 · Class II · Z-0648-2018: These finished good kits may contain the incorrect Springwire Guide (SWG).
- Oct 17, 2017 · Class II · Z-0652-2018: These finished good kits may contain the incorrect Springwire Guide (SWG).
- Oct 17, 2017 · Class II · Z-0657-2018: These finished good kits may contain the incorrect Springwire Guide (SWG).
- Oct 17, 2017 · Class II · Z-0650-2018: These finished good kits may contain the incorrect Springwire Guide (SWG).
- Oct 17, 2017 · Class II · Z-0654-2018: These finished good kits may contain the incorrect Springwire Guide (SWG).
- May 9, 2017 · Class II · Z-2336-2017: The Arrow CVC is indicated to provide short-term (<30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: -multiple infus
- Sep 18, 2014 · Class II · Z-0076-2015: Arrow International, Inc. has initiated a voluntary recall for product code AK- 12703, lot number RF3039028 because the label on the outer corrugate is labeled with the incorrect expiration date. All 
- Aug 6, 2014 · Class II · Z-0066-2015: The component supplier recalled their 0.9% Sodium Chloride Injection USP BD Posiflush SF Saline Flush Syringe 10mL because some unit packages may exhibit open seals which impact package integrity and 
- Jul 31, 2013 · Class II · Z-1965-2013: Arrow is recalling the product due to a labeling inconsistency. One portion of the lidstock states the kit contains a 3-Lumen catheter while the rest of the lidstock correctly identifies the catheter 
- Nov 9, 2010 · Not classified · Z-0898-2011: One lot of product was inadvertently mislabeled with a product lidstock identifying the product as a triple-lumen catheter with product number CV-15703, but a double-lumen catheter with part number CV
- Jun 17, 2009 · Not classified · Z-1653-2009: The spring wire guide is too large in diameter to pass through the needle, dilator and catheter.
- Feb 11, 2009 · Not classified · Z-1495-2009: Leakage: Material not lipid resistant, may crack and/or leak. Use of this device with lipid containing solutions or 70% isopropyl alcohol may cause leakage or air embolism.
- Sep 16, 2003 · Not classified · Z-0083-04: wrong product in box

Source page: https://510kreport.com/device/K862056
Methodology: https://510kreport.com/methodology