# K011761: Mac Two-Lumen Central Venous Kit with Arrowg Ard Blue Antimicrobial Surface and Integral Hemostasis Valve/Side Port

- Pathway: 510(k) (Traditional)
- Applicant: Arrow Intl., Inc.
- Decided: Oct 31, 2001 after 147 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- Recalls of this device: 10 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K895417 (1990). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
6 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993933: 14 FR Two-Lumen Hemodialysis Catherization Kit with Blue Flextip Arrowg+Ard Blue Catheter for High Volume Infusions, Pro, Arrow Intl., Inc. (2000) Summary page 1.
- K002507: Two-Lumen Central Venous Access Kit with Hemostasis Valve/Side Port, Arrow Intl., Inc. (2001) Summary page 1.
- K940079: Arrow Percutaneous Sheath Introducer Kit AK-07903, Arrow Intl., Inc. (1994) Summary page 1.

## Most influential descendants
- K032962: AC 3 Lumen Central Venous Access Kit with Arrowg+Ard Antimicrobial Surface (2003), 0 descendants of its own

## Recalls of this device
- Apr 21, 2026 · Class I · Z-2385-2026: 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
- Aug 6, 2019 · Class II · Z-2555-2019: Products may contain the incorrect banner card within the kit
- Apr 11, 2018 · Class II · Z-1983-2018: Product sterility may be compromised due to unsealed packaging.
- Dec 22, 2017 · Class II · Z-1324-2018: Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.
- Nov 27, 2017 · Class II · Z-1000-2018: Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI) information.
- Nov 27, 2017 · Class II · Z-1002-2018: Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI) information.
- May 9, 2017 · Class II · Z-2333-2017: Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility.
- Aug 27, 2015 · Class II · Z-2825-2015: Manufacturer of 0.9% Sodium Chloride Flush Syringes recalled due to compromised sterility of the outer barrel, Arrow purchased recalled items that were packaged with certain products.
- 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 
- Nov 24, 2009 · Not classified · Z-0783-2010: Q-Syte Component contained in kits was recalled by manufacturer due to the potential for embolism if used with a central venous catheter.

## Indications for use
The MAC™Two-Lumen Central Venous Access Device with ARROWg+ard Blue® permits venous access and catheter introduction to the central circulation. It may be inserted into the jugular, subclavian, or femoral veins. The ARROWg+ard® technology is intended to help provide protection against catheter-related infections. Clinical data have not been collected that demonstrate the use of the ARROWg+ard® antimicrobial surface in decreasing catheter-related infections for this device. It is not intended to be used as a treatment for existing infections, nor is it indicated for long-term use.

Source page: https://510kreport.com/device/K011761
Methodology: https://510kreport.com/methodology