# K962577: Arrowgard Blue Quad-Lumen Central Venous Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Arrow Intl., Inc.
- Decided: Aug 21, 1997 after 416 days
- Product code: FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days)
- Device class: 2
- Regulation: 21 CFR 880.5200
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
59 later devices descend from it; 4 cite it directly.
4 of 60 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K060174: Spectrum Five Lumen Central Venous Catheter Set, Model C-UQLM10.0-Abrm (2006), 32 descendants of its own
- K081113: Cook and Cook Spectrum Central Venous Catheters (2008), 31 descendants of its own
- K101326: NMI IC (2010), 26 descendants of its own
- K121089: Nmi Picc Iii (2012), 23 descendants of its own
- K111906: Xcela Hybrid Picc with Pasv Valve Technology (2011), 14 descendants of its own

## Recalls of this device
- Feb 11, 2009 · Not classified · Z-1497-2009: 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.

## Indications for use
The multiple-flumen catheter permits venous access to the central circulation. The Arrow antiseptic surface catheter is intended to help provide protection against catheter related infections. The catheter is not intended to be used as a treatment for existing infections nor is it indicated for longterm use.

Source page: https://510kreport.com/device/K962577
Methodology: https://510kreport.com/methodology