# K940079: Arrow Percutaneous Sheath Introducer Kit AK-07903

- Pathway: 510(k) (Traditional)
- Applicant: Arrow Intl., Inc.
- Decided: Nov 30, 1994 after 327 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
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
2 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K011761: Mac Two-Lumen Central Venous Kit with Arrowg Ard Blue Antimicrobial Surface and Integral Hemostasis Valve/Side Port (2001), 1 descendant of its own
- 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
- Apr 11, 2018 · Class II · Z-2018-2018: Product sterility may be compromised due to unsealed packaging.
- Apr 11, 2018 · Class II · Z-2017-2018: Product sterility may be compromised due to unsealed packaging.
- Apr 11, 2018 · Class II · Z-1975-2018: Product sterility may be compromised due to unsealed packaging.
- Apr 11, 2018 · Class II · Z-1986-2018: Product sterility may be compromised due to unsealed packaging.
- Dec 22, 2017 · Class II · Z-1334-2018: Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.
- Nov 14, 2017 · Class II · Z-1160-2018: Products do not contain the Central Venous Catheter Placement Procedures Note or the Central Line Insertion Checklist, which is a tool intended to guide clinicians in the use of best practices during 
- Nov 24, 2009 · Not classified · Z-0784-2010: Q-Syte Component contained in kits was recalled by manufacturer due to the potential for embolism if used with a central venous catheter.
- Feb 11, 2009 · Not classified · Z-1492-2009: 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.
- Jul 8, 2003 · Not classified · Z-1035-03: separation of sheath

Source page: https://510kreport.com/device/K940079
Methodology: https://510kreport.com/methodology