BARD BILIARY BALLOON DILATORS

Stents, Drains And Dilators For The Biliary Ducts

C.R. BARD, INC.

The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Bard Biliary Balloon Dilators.

Pre-market Notification Details

• Device ID: K920361
• 510k Number: K920361
• Device Name: BARD BILIARY BALLOON DILATORS
• Classification: Stents, Drains And Dilators For The Biliary Ducts
• Applicant: C.R. BARD, INC. 1200 TECHNOLOGY PARK DR. P.O. BOX 7025 Billerica, MA 01821
• Contact: Ernest Manfredo
• Correspondent: Ernest Manfredo; C.R. BARD, INC. 1200 TECHNOLOGY PARK DR. P.O. BOX 7025 Billerica, MA 01821
• Product Code: FGE
• CFR Regulation Number: 876.5010 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1992-01-27
• Decision Date: 1992-11-24

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00653405050926	K920361	000
00653405050919	K920361	000
00653405050905	K920361	000
20653405050916	K920361	000
20653405050923	K920361	000