# K171264: Royal Flush Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Cook Incorporated
- Decided: Jan 25, 2018 after 269 days
- Product code: DQO (Catheter, Intravascular, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 870.1200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K960806 (1996). 7 ancestors in all.
No later device cites it as a predicate yet.
1 of 8 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122937: Slip-Cath Beacon Tip Catheter Model SCBR (Product Prefix), Shuttle Select Slip-Cath Catheter Model SCBR (Product Prefix), Cook, Inc. (2012) Summary page 4.
- K113819: Mongoose Angiographic Catheter, Pediacath, Inc. (2012) Summary page 4.

## Indications for use
The Royal Flush Catheter are intended for the delivery of contrast media to the peripheral and coronary vasculature, not including the neurovasculature.

Source page: https://510kreport.com/device/K171264
Methodology: https://510kreport.com/methodology