FDA 510(k) Application Details - K240359

Device Classification Name Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days

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510(K) Number K240359
Device Name Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days
Applicant Becton, Dickinson and Company (Bard Access Systems, Inc.)
605 S 5600 W
Salt Lake City, UT 84116 US
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Contact Abigail Ryder
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Regulation Number 880.5200

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Classification Product Code FOZ
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Date Received 02/06/2024
Decision Date 07/29/2024
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K240359


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