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FDA 510(k) Application Details - K230281
Device Classification Name
Clamp, Vascular
More FDA Info for this Device
510(K) Number
K230281
Device Name
Clamp, Vascular
Applicant
Kono Seisakusho Co., Ltd
2-11-10
Soya
Ichikawa city 272-0837 JP
Other 510(k) Applications for this Company
Contact
Aya Takagi
Other 510(k) Applications for this Contact
Regulation Number
870.4450
More FDA Info for this Regulation Number
Classification Product Code
DXC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/01/2023
Decision Date
10/23/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
FDA Source Information for K230281
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