510(k) K171953

Bard Mission Disposable Core Biopsy Instrument by Bard Peripheral Vascular, Inc. — Product Code KNW

K171953 is an FDA 510(k) premarket notification submitted by Bard Peripheral Vascular, Inc. for the device "Bard Mission Disposable Core Biopsy Instrument". The FDA issued a decision of Substantially Equivalent on September 14, 2017. The device falls under product code KNW (Instrument, Biopsy), a Class II device regulated under 21 CFR 876.1075. Bard Peripheral Vascular, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 14, 2017
Date Received
June 29, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Instrument, Biopsy
Device Class
Class II
Regulation Number
876.1075
Review Panel
SU
Submission Type