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FDA 510(k) Application Details - K240257
Device Classification Name
Filter, Intravascular, Cardiovascular
More FDA Info for this Device
510(K) Number
K240257
Device Name
Filter, Intravascular, Cardiovascular
Applicant
BD
1625 W 3rd Street
Tempe, AL 85281 US
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Contact
Andrew Quach
Other 510(k) Applications for this Contact
Regulation Number
870.3375
More FDA Info for this Regulation Number
Classification Product Code
DTK
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/31/2024
Decision Date
02/29/2024
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
FDA Source Information for K240257
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