Atlas FDA

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

FDA 510(k) clearance K961841 · decided 1996-10-09

Clearance details

K-number
K961841
Device name
BARD V-MAX ROLLER BAR (3551XX;XX=01,02,03,04,05, OR 06)
Applicant
C.R. Bard, Inc.
Decision
Substantially Equivalent
Date received
1996-05-13
Decision date
1996-10-09
Days to decision
149 days
Clearance type
Traditional
Product code
FAS
Device class
2
Regulation number
876.4300
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Covington, GA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
Avitene Microfibrillar Collagen Hemostat (MCH) Non-Woven Web (P800002/S035)C.R. Bard, Inc.2026-07-15
Covera™ Vascular Covered Stent (P170042/S015)C.R. Bard, Inc.2026-06-10
Covera™ Vascular Covered Stent (P170042/S014)C.R. Bard, Inc.2025-12-16
Covera™ Vascular Covered Stents (P170042/S013)C.R. Bard, Inc.2025-06-26
Avitene Microfibrillar Collagen Hemostat (P800002/S033)C.R. Bard, Inc.2025-03-13
AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT NON-WOVEN WEB (P800002/S032)C.R. Bard, Inc.2025-02-18
Avitene™ Bulk Flour Cleanroom Expansion (P800002/S031)C.R. Bard, Inc.2024-01-18
Avitene™ Microfibrillar Collagen Hemostat (P800002/S030)C.R. Bard, Inc.2023-10-04