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FDA 510(k) Application Details - K221440
Device Classification Name
Introducer, Catheter
More FDA Info for this Device
510(K) Number
K221440
Device Name
Introducer, Catheter
Applicant
Bard Peripheral Vascular, Inc
1625 West 3rd Street
Tempe, AZ 85281 US
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Contact
Scott Johnson
Other 510(k) Applications for this Contact
Regulation Number
870.1340
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Classification Product Code
DYB
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More FDA Info for this Product Code
Date Received
05/17/2022
Decision Date
05/31/2022
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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