# K091188: Asahi Zenyteex Guiding Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Asahi Intecc Co., Ltd.
- Decided: Feb 26, 2010 after 309 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: 4 generations back to K981198 (1998). 10 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023402: 8F Launcher Guide Catheter, Medtronic Vascular (2002) Summary page 1.
- K022764: 7F Launcher Guide Catheter, Medtronic Vascular (2002) Summary page 1.
- K972484: Acs Viking Guiding Catheter, Guidant Corp. (1997) Summary page 1.
- K061601: Asahi Precious Guide Catheter, Asahi Intecc Co., Ltd. (2006) Summary page 1.
- K020028: 6F MACH1/34356-XXX; 5F MACH1/35845-XXX; 7F MACH1/34357-XXX; 8F MACH1/34358-XXX, Boston Scientific (2002) Summary page 1.

## Most influential descendants
- K132556: Sheathless Eaucath Coronary Guide Catheter (2013), 0 descendants of its own

## Indications for use
ASAHI ZenyteEX Guiding Catheter is intended for use in coronary or peripheral vascular 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. This device is not intended for use in the cerebral vasculature.

Source page: https://510kreport.com/device/K091188
Methodology: https://510kreport.com/methodology