FDA 510(k) Application Details - K203275

Device Classification Name Catheter, Percutaneous

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510(K) Number K203275
Device Name Catheter, Percutaneous
Applicant C.R. Bard, Inc.
1625 West 3rd St
Tempe, AZ 85281 US
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Contact Andrew Quach
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Regulation Number 870.1250

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Classification Product Code DQY
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Date Received 11/06/2020
Decision Date 03/01/2021
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 Y
Expedited Review



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