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FDA 510(k) Application Details - K192948
Device Classification Name
Instrument, Biopsy
More FDA Info for this Device
510(K) Number
K192948
Device Name
Instrument, Biopsy
Applicant
Bard Peripheral Vascular, Inc.
1625 West 3rd Street
Tempe, AZ 85281 US
Other 510(k) Applications for this Company
Contact
Meghan McKelvey
Other 510(k) Applications for this Contact
Regulation Number
876.1075
More FDA Info for this Regulation Number
Classification Product Code
KNW
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/18/2019
Decision Date
11/07/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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