BARD V-MAX ROLLER BAR (3551XX;XX=01,02,03,04,05, OR 06)— 510(k) K961841

Substantially Equivalent

C.R. Bard, Inc.

FDA 510(k) clearance K961841 for BARD V-MAX ROLLER BAR (3551XX;XX=01,02,03,04,05, OR 06), Substantially Equivalent on 1996-10-09. Applicant: C.R. Bard, Inc..

Clearance details

Applicant: C.R. Bard, Inc.
Product code: Code FAS
Advisory panel: Gastroenterology, Urology
Date received: 1996-05-13
Decision date: 1996-10-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Covington, GA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FAS

product code FAS

Death: 3
Injury: 344
Malfunction: 1,130
Total: 1,477

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.