# K160561: Boosting Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Qxmedical, LLC
- Decided: Nov 2, 2016 after 247 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K935425 (1994). 17 ancestors in all.
No later device cites it as a predicate yet.
1 of 18 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123311: Qxmedical Access & Support Catheter, Qxmedical, LLC (2013) Summary page 4.
- K132409: Concierge Guiding Catheter, Merit Medical Systems, Inc. (2013) Summary page 4.

## Indications for use
The Boosting Catheter is intended for use in conjunction with guiding catheters or sheaths during coronary and peripheral interventional procedures to guide and support interventional devices, including guidewires, traverse discrete portions of the vasculature, allow for interventional device exchanges and provide a conduit for infusion of saline solution, diagnostic contrast agents and therapeutic agents.

Source page: https://510kreport.com/device/K160561
Methodology: https://510kreport.com/methodology