# K820648: Arrow M.I.S. Multi-Lumen Catheteriza

- Pathway: 510(k) (Traditional)
- Applicant: Arrow Intl., Inc.
- Decided: Apr 14, 1982 after 36 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
14 later devices descend from it; 1 cites it directly.
1 of 15 devices in its family (counting itself) has 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
- K970864: Arrow-Howes Large Bore Multi-Lumen Central Venous Catheters (1997), 13 descendants of its own
- K014241: Coolgard 3000, Cooline, Start-UP, Models 3000, CL-2085B, CL-2295A, CG-500D (2003), 11 descendants of its own
- K101987: Cool Line Catheter, Model CL-2295A, Icy Catheter, Model IC-3893A and Quattro Catheter, Model IC-4593 (2010), 6 descendants of its own
- K150046: Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter (2015), 4 descendants of its own
- K141139: Solex Intravascular Heat Exchange Catheter (2014), 4 descendants of its own

## Recalls of this device
- Apr 11, 2018 · Class II · Z-2007-2018: Product sterility may be compromised due to unsealed packaging.
- Apr 11, 2018 · Class II · Z-2009-2018: Product sterility may be compromised due to unsealed packaging.
- Apr 11, 2018 · Class II · Z-2008-2018: Product sterility may be compromised due to unsealed packaging.
- Apr 11, 2018 · Class II · Z-2006-2018: Product sterility may be compromised due to unsealed packaging.
- Jul 29, 2010 · Not classified · Z-2490-2010: Incorrectly assembled 18 Ga x 2 1/2 Introducer Needle
- Jul 29, 2010 · Not classified · Z-2489-2010: Incorrectly assembled 18 Ga x 2 1/2 Introducer Needle
- Jul 29, 2010 · Not classified · Z-2492-2010: Incorrectly assembled 18 Ga x 2 1/2 Introducer Needle

Source page: https://510kreport.com/device/K820648
Methodology: https://510kreport.com/methodology