FDA 510(k) Application Details - K240257

Device Classification Name Filter, Intravascular, Cardiovascular

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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
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Regulation Number 870.3375

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Classification Product Code DTK
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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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