# K161801: CrossCath Support Catheter

- Pathway: 510(k) (Special)
- Applicant: Cook Incorporated
- Decided: Jul 29, 2016 after 29 days
- Product code: KRA (Catheter, Continuous Flush)
- Device class: 2
- Regulation: 21 CFR 870.1210
- Recalls of this device: 4 (4 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K052841 (2005). 4 ancestors in all.
No later device cites it as a predicate yet.
1 of 5 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093052: Crosscath Support Cathter, Cook, Inc. (2009) Summary page 4.

## Recalls of this device
- Nov 8, 2019 · Class I · Z-0588-2020: A manufacturing error may cause the radiopaque marker bands to be too loose on certain CXC3.0 CrossCath Support Catheters (compatible with 0.014 wire guides) and too tight on certain CXC3.4 CrossCath 
- Nov 8, 2019 · Class I · Z-0589-2020: A manufacturing error may cause the radiopaque marker bands to be too loose on certain CXC3.0 CrossCath Support Catheters (compatible with 0.014 wire guides) and too tight on certain CXC3.4 CrossCath 
- Nov 8, 2019 · Class I · Z-0587-2020: A manufacturing error may cause the radiopaque marker bands to be too loose on certain CXC3.0 CrossCath Support Catheters (compatible with 0.014 wire guides) and too tight on certain CXC3.4 CrossCath 
- Nov 8, 2019 · Class I · Z-0590-2020: A manufacturing error may cause the radiopaque marker bands to be too loose on certain CXC3.0 CrossCath Support Catheters (compatible with 0.014 wire guides) and too tight on certain CXC3.4 CrossCath 

## Indications for use
The CrossCath Support Catheter is intended for use in small vessel or superselective anatomy for diagnostic and interventional procedures, including peripheral use.

Source page: https://510kreport.com/device/K161801
Methodology: https://510kreport.com/methodology