# K061601: Asahi Precious Guide Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Asahi Intecc Co., Ltd.
- Decided: Nov 17, 2006 after 162 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: 2 generations back to K010874 (2001). 2 ancestors in all.
109 later devices descend from it; 3 cite it directly.
0 of 112 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020028: 6F MACH1/34356-XXX; 5F MACH1/35845-XXX; 7F MACH1/34357-XXX; 8F MACH1/34358-XXX, Boston Scientific (2002) Summary page 1.
- K010874: 6F Mach 1, Model 34356-XXX, Boston Scientific Corp (2001) Summary page 1.

## Most influential descendants
- K093268: Intellivue Patient Monitor (2010), 105 descendants of its own
- K102562: Intellivue Patient Monitor, Models MP2, X2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90, & MX800 (2010), 103 descendants of its own
- K110622: Intellivue Patient Monitor (2011), 90 descendants of its own
- K110474: Philips Intellivue TCG10 (2011), 84 descendants of its own
- K113657: Intellivue Patient Monitor (2012), 81 descendants of its own

## Indications for use
The ASAHI Precious guide catheter is intended for use in coronary artery applications and is designed to provide a pathway through which medical instruments, such as balloon catheters, guide wires or other therapeutic devices may be introduced. These devices are not intended for use in the cerebral vasculature.

Source page: https://510kreport.com/device/K061601
Methodology: https://510kreport.com/methodology