Atlas FDA

VACORA VACUUM ASSISTED BIOPSY SYSTEM

FDA 510(k) clearance K082681 · decided 2008-10-15

Clearance details

K-number
K082681
Device name
VACORA VACUUM ASSISTED BIOPSY SYSTEM
Applicant
C.R. Bard, Inc.
Decision
Substantially Equivalent
Date received
2008-09-15
Decision date
2008-10-15
Days to decision
30 days
Clearance type
Special
Product code
KNW
Device class
2
Regulation number
876.1075
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Tempe, AZ, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Plastic Radiolucent Coaxial for 10gx118 (Catalog VC10118P). recall (Z-1879-2009)Bard Peripheral Vas2009-08-26
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MR Coaxial 10g x 140mm (VC10140MR). recall (Z-1881-2009)Bard Peripheral Vas2009-08-26
MR Coaxial 10g x 118mm (VC10118MR). recall (Z-1882-2009)Bard Peripheral Vas2009-08-26

PMA approvals by this applicant

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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
Covera™ Vascular Covered Stent (P170042/S012)C.R. Bard, Inc.2023-02-02
Avitene Microfibrillar Collagen Hemostat (MCH) Non-Woven Web and Avitene Microfibrillar Collagen Hemostat (MCH) EndoAvit (P800002/S027)C.R. Bard, Inc.2022-04-01