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FDA 510(k) Application Details - K220280
Device Classification Name
Stylet, Catheter
More FDA Info for this Device
510(K) Number
K220280
Device Name
Stylet, Catheter
Applicant
Arrow International, LLC (a subsidiary of Teleflex, Inc.)
3015 Carrington Mill Blvd
Morrisville, NC 27560 US
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Contact
Fallon Young
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Regulation Number
870.1380
More FDA Info for this Regulation Number
Classification Product Code
DRB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/01/2022
Decision Date
08/30/2022
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
N
Expedited Review
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