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FDA 510(k) Application Details - K151678
Device Classification Name
Catheter, Angioplasty, Peripheral, Transluminal
More FDA Info for this Device
510(K) Number
K151678
Device Name
Catheter, Angioplasty, Peripheral, Transluminal
Applicant
AV Medical Technologies Ltd
21b Habarzel Street
Tel Aviv 6971029 IL
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Contact
Limor Sandach
Other 510(k) Applications for this Contact
Regulation Number
870.1250
More FDA Info for this Regulation Number
Classification Product Code
LIT
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/22/2015
Decision Date
09/21/2015
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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