# K970864: Arrow-Howes Large Bore Multi-Lumen Central Venous Catheters

- Pathway: 510(k) (Traditional)
- Applicant: Arrow Intl., Inc.
- Decided: Oct 17, 1997 after 221 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: 4 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K820648 (1982). 4 ancestors in all.
13 later devices descend from it; 2 cite it directly.
3 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K820648: Arrow M.I.S. Multi-Lumen Catheteriza, Arrow Intl., Inc. (1982) Summary page 1.
- K844080: Arrow-Geiss Percutaneous TPN Kit, Arrow Intl., Inc. (1985) Summary page 1.
- K862056: [Central Venous][Multi-Lumen] Catheter W/Flex Tip, Arrow Intl., Inc. (1986) Summary page 1.
- K895417: Arrow Large-Bore Dual Lumen Hemodialysis Kit, Arrow Intl., Inc. (1990) Summary page 1.

## Most influential descendants
- 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
- K153226: Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up Kit (2016), 3 descendants of its own

## Recalls of this device
- Apr 21, 2026 · Class I · Z-2376-2026: 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
- May 5, 2022 · Class II · Z-1290-2022: Gravity flow rates on the affected product lidstock are incorrect.
- May 8, 2009 · Not classified · Z-1672-2009: Wire guide can have difficulty passing through catheter juncture hub or being removed from the catheter.
- May 8, 2009 · Not classified · Z-1671-2009: Wire guide can have difficulty passing through catheter juncture hub or being removed from the catheter.

## Indications for use
The large-bore multiple lumen catheter permits venous access to a central circulation for rapid fluid administration. It may be inserted into the jugular, subclavian, and femoral veins. The heparin coating on the catheter intended to decrease the incidence of thrombus formation associated with catheterization.

Source page: https://510kreport.com/device/K970864
Methodology: https://510kreport.com/methodology