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FDA 510(k) Application Details - K171176
Device Classification Name
Catheter, Percutaneous
More FDA Info for this Device
510(K) Number
K171176
Device Name
Catheter, Percutaneous
Applicant
Acrostak (Schweiz) AG
Stegackerstrasse 14
Winterthur 8409 CH
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Contact
Carmen Herraez
Other 510(k) Applications for this Contact
Regulation Number
870.1250
More FDA Info for this Regulation Number
Classification Product Code
DQY
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/21/2017
Decision Date
09/15/2017
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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