DURAGLIDE STONE REMOVAL BALLOON, MODEL 000635-38, 000646-47, DURAGLIDE STONE BALLOON, MODEL 007124-25,007144-45

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 Duraglide Stone Removal Balloon, Model 000635-38, 000646-47, Duraglide Stone Balloon, Model 007124-25,007144-45.

Pre-market Notification Details

• Device ID: K993892
• 510k Number: K993892
• Device Name: DURAGLIDE STONE REMOVAL BALLOON, MODEL 000635-38, 000646-47, DURAGLIDE STONE BALLOON, MODEL 007124-25,007144-45
• Classification: Stents, Drains And Dilators For The Biliary Ducts
• Applicant: C.R. BARD, INC. 129 CONCORD RD., BLDG. #3 Billerica, MA 01821
• Contact: Marion Gordon
• Correspondent: Marion Gordon; C.R. BARD, INC. 129 CONCORD RD., BLDG. #3 Billerica, MA 01821
• Product Code: FGE
• CFR Regulation Number: 876.5010 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1999-11-16
• Decision Date: 2000-01-06
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00653405053753	K993892	000
00653405053746	K993892	000
00653405053739	K993892	000
00653405053722	K993892	000
00653405053715	K993892	000
00653405053708	K993892	000
20653405053757	K993892	000
20653405053733	K993892	000