BONCHEK-SHILEY VEIN DISTENTION SYSTEM

Dilator, Vessel, Surgical

SHILEY, INC.

The following data is part of a premarket notification filed by Shiley, Inc. with the FDA for Bonchek-shiley Vein Distention System.

Pre-market Notification Details

• Device ID: K792134
• 510k Number: K792134
• Device Name: BONCHEK-SHILEY VEIN DISTENTION SYSTEM
• Classification: Dilator, Vessel, Surgical
• Applicant: SHILEY, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: DWP
• CFR Regulation Number: 870.4475 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1979-10-22
• Decision Date: 1979-12-04

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10803622133135	K792134	000
10803622133128	K792134	000
10803622133111	K792134	000