Stockert-Shiley Venous Catheter and Aortic Arch Cannula
by Shiley, Inc. 510(k)
Active
510(k) K861496
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK861496 | Date27 May 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- Withdrawn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
- Full name
- Stockert-Shiley Venous Cath & Aortic Arch Cannula
- 510(k) Number
- FDA Product Code
- DWF
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.4210
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 25 Sep 2026
The Stockert-Shiley Venous Catheter and Aortic Arch Cannula is a vascular device used for cardiopulmonary bypass. It is categorized as a catheter, cannula, and tubing system designed to facilitate blood flow during cardiovascular procedures.
This device is authorized under FDA 510(k) clearance K861496. It is manufactured by Shiley, Inc. and is classified as a Class II medical device.
Other devices from Shiley, Inc.
Questions
AI-generated answers, 25 Sep 2026
What is the primary purpose of the Stockert-Shiley Venous Catheter and Aortic Arch Cannula?
This device is a vascular catheter, cannula, and tubing system specifically designed to facilitate blood flow during cardiopulmonary bypass procedures.
What is the regulatory classification of this device?
The Stockert-Shiley Venous Catheter and Aortic Arch Cannula is classified as a Class II medical device and is authorized under FDA 510(k) clearance K861496.
Who is the manufacturer of this vascular device?
The device is manufactured by Shiley, Inc., located in Irvine, California.