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FDA 510(k) Application Details - K171146
Device Classification Name
Catheter, Percutaneous
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510(K) Number
K171146
Device Name
Catheter, Percutaneous
Applicant
Arrow International, Inc. (Subsidiary of Telelflex Inc.)
2400 Bernville Road
Reading, PA 19605 US
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Contact
Fallon Young
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Regulation Number
870.1250
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Classification Product Code
DQY
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More FDA Info for this Product Code
Date Received
04/19/2017
Decision Date
06/23/2017
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
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