Schneider-Shiley Flushing Catheter
by Shiley, Inc. 510(k)
Active
510(k) K862466
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK862466 | Date29 Aug 1986 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- DQO
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1200
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 22 Sep 2026
The Schneider-Shiley Flushing Catheter is an intravascular diagnostic catheter. It is designed to facilitate flushing procedures within the cardiovascular system.
This device is identified by FDA 510(k) number K862466. It is manufactured by Shiley, Inc. and is classified under product code DQO.
Other devices from Shiley, Inc.
Questions
AI-generated answers, 22 Sep 2026
What is the primary function of the Schneider-Shiley Flushing Catheter?
This device is an intravascular diagnostic catheter specifically engineered to facilitate flushing procedures within the cardiovascular system.
How is this device classified for regulatory purposes?
The Schneider-Shiley Flushing Catheter is identified under FDA 510(k) number K862466 and is categorized under product code DQO, which pertains to cardiovascular diagnostic equipment.
Who is the manufacturer of this flushing catheter?
The device is manufactured by Shiley, Inc., located in Irvine, California.