Bonchek-Shiley Vein Distention System
by Shiley, Inc. 510(k)
Active
510(k) K792134
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK792134 | Date4 Dec 1979 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- DWP
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.4475
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Bonchek-Shiley Vein Distention System is a surgical dilator designed for the controlled distention and irrigation of veins, specifically the saphenous vein, in preparation for transplantation. It is classified as a vessel dilator and falls under the category of cardiovascular surgical devices. The system facilitates the controlled expansion of veins to ensure proper preparation for surgical procedures.
This device is intended for use in surgical settings and is classified as a Class II medical device under FDA regulations (DWP product code). It is supplied as a reusable instrument and is not described as sterile or single-use in the provided data. The system’s regulatory submission (K792134) was reviewed by the FDA’s Cardiovascular Advisory Committee in 1979 and granted a 510(k) clearance under the Traditional pathway. No additional details regarding MRI safety, specific sizes, or storage conditions are provided in the available data.
Other devices from Shiley, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Bonchek-Shiley Vein Distention System used for?
The Bonchek-Shiley Vein Distention System is designed specifically for the controlled distention and irrigation of veins, particularly the saphenous vein, in preparation for surgical transplantation. By facilitating gradual vein expansion, it ensures proper preparation for procedures requiring vascular access or grafting.
Is the Bonchek-Shiley Vein Distention System reusable or single-use?
The Bonchek-Shiley Vein Distention System is supplied as a reusable instrument. Reusability is common for surgical tools in controlled environments where proper cleaning, sterilization, and maintenance protocols are followed to ensure safety and functionality across multiple procedures.
What regulatory pathway was followed for FDA clearance of this device?
The Bonchek-Shiley Vein Distention System received FDA clearance under the Traditional 510(k) pathway in 1979. The submission (K792134) was reviewed by the FDA’s Cardiovascular Advisory Committee, which determined it was substantially equivalent to a legally marketed predicate device, allowing for its commercialization as a Class II medical device.
Does the system come with specific sizes or models?
The provided data does not specify individual sizes or model variations for the Bonchek-Shiley Vein Distention System. However, as a surgical dilator, it likely includes components tailored to accommodate different vein diameters or procedural requirements. For precise sizing details, refer to the manufacturer’s technical documentation or contact Shiley, Inc.
Are there any special storage requirements for this device?
The available data does not detail specific storage conditions for the Bonchek-Shiley Vein Distention System. As a reusable instrument, it should be stored in a clean, dry environment to prevent contamination or damage. Follow the manufacturer’s guidelines for maintenance, cleaning, and sterilization to ensure proper functionality and longevity.